Tissue sample holder with enhanced features

ABSTRACT

A biopsy device includes a body, a needle, a cutter, an analysis area, a valve, and a tissue sample holder. The cutter is movable relative to the needle and in communication with the needle for transporting tissue samples. The analysis area is disposed proximally of the cutter and in communication with the needle to receive a tissue sample cut by the cutter for analysis by a user. The valve is disposed proximally of the analysis area and configured to alternate between an open configuration and a closed configuration. The tissue sample holder is disposed proximally of the valve and fixedly attached to the body. The valve is configured to permit analysis of the sample disposed in the analysis area when the valve is in the closed configuration and to permit the tissue sample to be passed into the tissue sample holder when the valve is in the open configuration configuration.

PRIORITY

The present application claims priority to U.S. Provisional PatentApplication No. 62/329,346, entitled “Tissue Sample Holder with EnhancedFeatures,” filed on Apr. 29, 2016, the disclosure of which is herebyincorporated by reference in its entirety.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures including open and percutaneous methods using avariety of devices. For instance, some biopsy devices may be fullyoperable by a user using a single hand, and with a single insertion, tocapture one or more biopsy samples from a patient. In addition, somebiopsy devices may be tethered to a vacuum module and/or control module,such as for communication of fluids (e.g., pressurized air, saline,atmospheric air, vacuum, etc.), for communication of power, and/or forcommunication of commands and the like. Other biopsy devices may befully or at least partially operable without being tethered or otherwiseconnected with another device. Biopsy devices may be used understereotactic guidance, ultrasound guidance, MRI guidance, PositronEmission Mammography (“PEM” guidance), Breast-Specific Gamma Imaging(“BSGI”) guidance or otherwise.

The state of the art technology for conducting a breast biopsy is to usea vacuum-assisted breast biopsy device. A current textbook in this areais “Vacuum-Assisted Breast Biopsy with Mammotome®”, available Nov. 11,2012, copyright 2013 by Devicor Medical Germany GmBh, published inGermany by Springer Medizin Verlag, Authors: Markus Hahn, Anne Tardivonand Jan Casselman, ISBN 978-3-642-34270-7.

Merely exemplary biopsy devices and biopsy system components aredisclosed in U.S. Pat. No. 5,526,822, entitled “Method and Apparatus forAutomated Biopsy and Collection of Soft Tissue,” issued Jun. 18, 1996;U.S. Pat. No. 5,928,164, entitled “Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jul. 27, 1999; U.S. Pat. No.6,017,316, entitled “Vacuum Control System and Method for AutomatedBiopsy Device,” issued Jan. 25, 2000; U.S. Pat. No. 6,086,544, entitled“Control Apparatus for an Automated Surgical Biopsy Device,” issued Jul.11, 2000; U.S. Pat. No. 6,162,187, entitled “Fluid Collection Apparatusfor a Surgical Device,” issued Dec. 19, 2000; U.S. Pat. No. 6,432,065,entitled “Method for Using a Surgical Biopsy System with Remote Controlfor Selecting an Operational Mode,” issued Aug. 13, 2002; U.S. Pat. No.6,626,849, entitled “MRI Compatible Surgical Biopsy Device,” issued Sep.11, 2003; U.S. Pat. No. 6,752,768, entitled “Surgical Biopsy System withRemote Control for Selecting an Operational Mode,” issued Jun. 22, 2004;U.S. Pat. No. 7,442,171, entitled “Remote Thumbwheel for a SurgicalBiopsy Device,” issued Oct. 8, 2008; U.S. Pat. No. 7,648,466, entitled“Manually Rotatable Piercer,” issued Jan. 19, 2010; U.S. Pat. No.7,837,632, entitled “Biopsy Device Tissue Port Adjustment,” issued Nov.23, 2010; U.S. Pat. No. 7,854,706, entitled “Clutch and Valving Systemfor Tetherless Biopsy Device,” issued Dec. 1, 2010; U.S. Pat. No.7,914,464, entitled “Surgical Biopsy System with Remote Control forSelecting an Operational Mode,” issued Mar. 29, 2011; U.S. Pat. No.7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device,” issuedMay 10, 2011; U.S. Pat. No. 8,083,687, entitled “Tissue Biopsy Devicewith Rotatably Linked Thumbwheel and Tissue Sample Holder,” issued Dec.21, 2011; U.S. Pat. No. 8,118,755, entitled “Biopsy Sample Storage,”issued. Feb. 1, 2012; U.S. Pat. No. 8,206,316, entitled “TetherlessBiopsy Device with Reusable Portion,” issued on Jun. 26, 2012; U.S. Pat.No. 8,241,226, entitled “Biopsy Device with Rotatable Tissue SampleHolder,” issued on Aug. 14, 2012; U.S. Pat. No. 8,251,916, entitled“Revolving Tissue Sample Holder for Biopsy Device,” issued Aug. 28,2012; U.S. Pat. No. 8,454,531, entitled “Icon-Based User interface onBiopsy System Control Module,” published May 21, 2009, issued on Jun. 4,2013; U.S. Pat. No. 8,532,747, entitled “Biopsy Marker Delivery Device,”issued Sep. 10, 2013; U.S. Pat. No. 8,702,623, entitled “Biopsy Devicewith Discrete Tissue Chambers,” issued on Apr. 22, 2014; U.S. Pat. No.8,764,680, entitled “Handheld Biopsy Device with Needle Firing,” issuedon Jun. 11, 2014; U.S. Pat. No. 8,801,742, entitled “Needle Assembly andBlade Assembly for Biopsy Device,” issued Aug. 12, 2014; U.S. Pat. No.8,858,465, entitled “Biopsy Device with Motorized Needle Firing,” issuedOct. 14, 2014; U.S. Pat. No. 8,938,285, entitled “Access Chamber andMarkers for Biopsy Device,” issued Jan. 20, 2015; U.S. Pat. No.9,095,326, entitled “Biopsy System with Vacuum Control Module,” issued.Aug. 4, 2015 and U.S. Pat. No. 9,095,326, entitled “Biopsy System withVacuum Control Module,” issued Aug. 4, 2015. The disclosure of each ofthe above-cited. U.S. patents is incorporated by reference herein.

Additional exemplary biopsy devices and biopsy system components aredisclosed in U.S. Pat. Pub. No. 2006/0074345, entitled “Biopsy Apparatusand Method,” published Apr. 6, 2006 and now abandoned; U.S. Pat. Pub.No. 2008/0214955, entitled “Presentation of Biopsy Sample by BiopsyDevice,” published Sep. 4, 2008; U.S. Pat. Pub. No. 2009/0131821,entitled “Graphical User Interface For Biopsy System Control Module,”published. May 21, 2009, now abandoned; U.S. Pat. Pub. No. 2010/0152610,entitled “Hand Actuated Tetherless Biopsy Device with Pistol Grip,”published Jun. 17, 2010, now abandoned; U.S. Pat. Pub. No. 2010/0160819,entitled “Biopsy Device with Central Thumbwheel,” published Jun. 24,2010, now abandoned; U.S. Pat. Pub. No. 2013/0053724, entitled “BiopsyDevice Tissue Sample Holder with Bulk Chamber and Pathology Chamber,”published Feb. 28, 2013, will issue on May 3, 2016 as U.S. Pat. No.9,326,755; U.S. Pat. Pub. No. 2013/0144188, entitled “Biopsy Device WithSlide-In Probe,” published. Jun. 6, 2013; and U.S. Pat. Pub. No.2013/0324882, entitled “Control for Biopsy Device,” published Dec. 5,2013. The disclosure of each of the above-cited U.S. patent applicationPublications, U.S. Non-Provisional Patent Applications, and U.S.Provisional Patent Applications is incorporated by reference herein.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventor hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim this technology, it is believed this technologywill be better understood from the following description of certainaspects taken in conjunction with the accompanying drawings, in whichlike reference numerals identify the same elements and in which:

FIG. 1 depicts a perspective view of a probe for use with the biopsydevice described and shown in FIGS. 1-12 of U.S. Pub. No. 2014/0039343,“Biopsy System”, published on 6 Feb. 2014. The published U.S. PatentApplication is incorporated by reference in its entirety.

FIG. 2; depicts an exploded perspective view of a tissue sample holderof the probe of FIG. 1;

FIG. 3 depicts a perspective view of a sample basket of the tissuesample holder of FIG. 2;

FIG. 4 depicts a perspective exploded view of a sample managementassembly of the probe of FIG. 1;

FIG. 5 depicts a front elevational view of the sample managementassembly of FIG. 4;

FIG. 6 depicts a perspective partial cut-away view of the samplemanagement assembly of FIG. 4;

FIG. 7 depicts a depicts a side cross-sectional view of the probe ofFIG. 1, with the cross-section taken along line 19-19 of FIG. 1 and thesample management assembly in a tissue blocking configuration;

FIG. 8 depicts a rear elevational view of the probe of FIG. 1, with thesample basket of FIG. 3 removed and the sample management assembly in atissue blocking configuration;

FIG. 9 depicts another cross-sectional view of the probe of FIG. 1, withthe sample management assembly in a tissue transport configuration;

FIG. 10 depicts another rear elevational view of the probe of FIG. 1,with the sample basket of FIG. 3 removed and the sample managementassembly in a tissue transport configuration;

FIG. 11 depicts a perspective view of an alternative probe for use withthe biopsy device of FIG. 2;

FIG. 12 depicts an exploded perspective view of a tissue sample holderfor use with the probe of FIG. 11;

FIG. 13 depicts a perspective view of an outer cover of the tissuesample holder of FIG. 12;

FIG. 14 depicts a perspective cross-sectional view of the outer cover ofFIG. 13, the cross-section taken along line 26-26 of FIG. 13;

FIG. 15 depicts a perspective view of a sample management assembly foruse with the tissue sample holder of FIG. 12;

FIG. 16 depicts a side cross-sectional view of the probe of FIG. 11,with the cross-section taken along line 28-28 of FIG. 11 and the samplemanagement assembly in a tissue blocking configuration;

FIG. 17 depicts a front elevational view of the probe of FIG. 11 withthe sample basket removed and the sample management assembly in a tissueblocking configuration;

FIG. 18 depicts another side cross-sectional view of the probe of FIG.11, with the sample management assembly in a tissue transportconfiguration;

FIG. 19 depicts another front elevational view of the probe of FIG. 11with the sample basket removed and the sample management assembly in atissue transport configuration;

FIG. 20 depicts a perspective view of another aspect of an alternativesample management assembly for incorporation into the tissue sampleholder of FIG. 12;

FIG. 21 depicts a perspective view of an alternative tissue sampleholder for use with any one of the probes;

FIG. 22 depicts an exploded perspective view of the tissue sample holderof FIG. 21;

FIG. 23 depicts a perspective view of a sample management assembly foruse with the tissue sample holder of FIG. 21;

FIG. 24 depicts an partial cut-away side view of the tissue sampleholder of FIG. 21, with the sample management assembly in a first samplereceiving configuration;

FIG. 25 depicts a front elevational view of the tissue sample holder ofFIG. 21, with a sample basket removed and the sample management assemblyin the second sample receiving configuration;

FIG. 26 depicts another partial cut-away side view of the tissue sampleholder of FIG. 21, with the sample management assembly in a secondsample receiving configuration;

FIG. 27 depicts another front elevational view of the tissue sampleholder of FIG. 21, with the sample basket removed and the samplemanagement assembly in the second sample receiving configuration;

FIG. 28 depicts a perspective view of an exemplary alternative tissuesample holder for use with any one of the probes.

FIG. 29 depicts a perspective exploded view of the tissue sample holderof FIG. 28;

FIG. 30 depicts a perspective cross-sectional view of the tissue sampleholder of FIG. 28, with the cross-section taken along line 42-42 of FIG.28;

FIG. 31 depicts a front elevational view of an outer cover of the tissuesample holder of FIG. 28;

FIG. 32 depicts a rear elevational view of the outer cover of FIG. 31;

FIG. 33 depicts a perspective cross-sectional view of the outer cover ofFIG. 31, the cross-section taken along line 45-45 of FIG. 32;

FIG. 34 depicts a perspective view of a sample management assembly foruse with the tissue sample holder of FIG. 40;

FIG. 35 depicts a front elevational view of a rotational cam plate ofthe sample management assembly of FIG. 34;

FIG. 36 depicts a front elevational view of a stationary cam plate ofthe sample management assembly of FIG. 34;

FIG. 37 depicts a perspective view of the sample management assembly ofFIG. 34, with at least some cam plates removed;

FIG. 38 depicts a front elevational view of the tissue sample holder ofFIG. 28;

FIG. 39 depicts a rear elevational view of the tissue sample holder ofFIG. 28, with a sample basket removed;

FIG. 40 depicts a front elevational view of the sample managementassembly of FIG. 34, with the sample management assembly in a tissuereceiving position;

FIG. 41 depicts another front elevational view of the sample managementassembly of FIG. 34, with the sample management assembly in anintermediate position;

FIG. 42 depicts still another front elevational view of the samplemanagement assembly of FIG. 34, with the sample management assembly in afirst tissue ejection position;

FIG. 43 depicts yet another front elevational view of the samplemanagement assembly of FIG. 34, with the sample management assembly in asecond tissue ejection position;

FIG. 44 depicts a perspective view of still another exemplaryalternative tissue sample holder for use with any one of the probes.

FIG. 45 depicts an exploded perspective view of the tissue sample holderof FIG. 44;

FIG. 46 depicts a perspective view of a sample management assembly foruse with the tissue sample holder of FIG. 44;

FIG. 47 depicts a side cross-sectional view of the sample managementassembly of FIG. 46, the cross-section taken along line 59-59 of FIG.46; and

FIG. 48 depicts another perspective view of the sample managementassembly of FIG. 46, with the sample management assembly in a tissuereleasing configuration.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the technology may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presenttechnology, and together with the description serve to explain theprinciples of the technology; it being understood, however, that thistechnology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain aspects of the technology shouldnot be used to limit its scope. Other aspects, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

FIGS. 1-12 of U.S. Pub. No. 2014/0039343, “Biopsy System”, published on6 Feb. 2014, describe an exemplary biopsy system. As previously stated,the published U.S. Patent Application is incorporated by reference in usentirety.

FIG. 1 shows an exemplary alternative probe (1100) that can be readilyincorporated into the biopsy device described in U.S. Pub. No.2014/0039343. It should be understood that except as otherwise notedherein, probe (1100) is substantially the same as the probe described inU.S. Pub. No. 2014/0039343. Unlike the probe in U.S. Pub. No.2014/0039343, probe (1100) of the present aspect is generally configuredto permit individual analysis of a tissue sample using a tissue analysisfeature that will be described in greater detail below. Probe (1100) isfurther configured to store tissue samples in a bulk configuration. Aswill be described in greater detail below, probe (1100) generallyincludes features to permit temporary isolation of a single tissuesample followed by deposit in a single bulk tissue chamber (1346).

Probe (1100) of the present aspect includes a needle (1110) extendingdistally from probe (1100) that is inserted into a patient's tissue toobtain tissue samples. These tissue samples are deposited in a tissuesample holder (1300) at the proximal end of probe (1100). As withrespect to the probe described in U.S. Pub. No. 2014/0039343, a vacuumcontrol module can be coupled with probe (1100) via a valve assembly andtubes (1020, 1030), which is operable to selectively provide vacuum,saline, atmospheric air, and venting to probe (1100). Probe (1100) alsoincludes a top housing (1102) or body that generally defines an exteriorsurface of probe (1100) for gripping by an operator to manipulate needle(1110). Although not shown, it should be understood that probe (1100)includes gears or other feature similar to gears described in U.S. Pub.No. 2014/0039343. As with respect to the probe described in U.S. Pub.No. 2014/0039343, such gears and/or other features are operable to drivea cutter actuation mechanism in probe (1100) to rotate and translate acutter (not shown) disposed within needle (1110).

Needle (1110) is substantially the same as the needle described in U.S.Pub. No. 2014/0039343. For instance, needle (1110) of the present aspectcomprises a cannula (1113) having a piercing tip (1112), a lateralaperture (1114) located proximal to tip (1112). Although not shown, itshould be understood that in some aspects needle (1110) also includes ahub member (not shown) similar to the hub member described in U.S. Pub.No. 2014/0039343. As similarly described in U.S. Pub. No. 2014/0039343with respect to tip, tip (1112) of the needle (1110) is configured topierce and penetrate tissue, without requiring a high amount of force,and without requiring an opening to be pre-formed in tissue prior toinsertion of tip (1112).

Lateral aperture (1114) is also substantially similar to lateralaperture described in U.S. Pub. No. 2014/0039343. For instance, lateralaperture (1114) is sized to receive prolapsed tissue during operation ofthe biopsy device described in U.S. Pub. No. 2014/0039343. Although notshown, it should be understood that a hollow tubular cutter (not shown)is disposed within needle. The cutter in the present aspect issubstantially similar to the cutter described in U.S. Pub. No.2014/0039343 such that the cutter is operable to rotate and translaterelative to needle (1110) and past lateral aperture (1114) to sever atissue sample from tissue protruding through lateral aperture (1114).Needle (1110) of the present aspect is similar to the needle describedin U.S. Pub. No. 2014/0039343 with respect to being rotated about thelongitudinal axis of needle (1110) to orient lateral aperture (1114) atany desired axial position.

As described above, probe (1100) includes housing (1102), which supportsthe internal components of probe (1100). Needle (1110) protrudesdistally from housing (1102) and is supported by housing (1102) suchthat an operator can manipulate needle (1110) by grasping housing(1102). Unlike the housing described in U.S. Pub. No. 2014/0039343,housing (1102) of the present aspect includes tissue window (1103). Aswill be described in greater detail below, tissue window (1103) providesa tissue analysis feature by providing a transparent window throughwhich an individual tissues sample may be viewed by an operator.

The proximal end of housing (1102) supports a tissue sample holder(1300) that is similar to the tissue sample holder described in U.S.Pub. No. 2014/0039343. However, unlike the tissue sample holderdescribed in U.S. Pub. No. 2014/0039343, tissue sample holder (1300) ofthe present aspect is configured to store tissue samples in a singlebulk tissue sample chamber (1346). As is best seen in FIG. 2, tissuesample holder (1300) comprises a sealing member (1170), a sample basket(1330), a sample management assembly (1310), and an outer cover (1302).Sealing member (1170) of the present aspect is substantially the same asthe sealing member described in U.S. Pub. No. 2014/0039343.

Sealing member (1170) of the present aspect includes a longitudinallyextending cutter seal (1172), which receives the cutter disposed inneedle (1110) and seals against the exterior of the cutter. The proximalend of the cutter remains within cutter seal through the full range oftravel of the cutter such that cutter seal (1172) maintains a fluidtight seal as the cutter is actuated for tissue sampling. Also like thesealing member described in U.S. Pub. No. 2014/0039343 with respect tothe needle, an opening (not shown) is positioned at the proximal end ofthe cutter seal (1172). As will be described in greater detail below,this opening is configured to align with a particular portion of samplemanagement assembly (1310) to transmit tissue samples to sample basket(1330).

Sealing member (1170) further includes a first vacuum opening (1174) anda second vacuum opening (1176). First vacuum opening (1174) ispositioned below cutter seal (1172). First vacuum opening (1174) issubstantially similar to the opening of sealing member described in U.S.Pub. No. 2014/0039343, However, unlike the sealing member described inU.S. Pub. No. 2014/0039343, sealing member (1170) of the present aspectadditionally includes second vacuum opening (1176) disposed near thebottom of sealing member (1170). As will be described in greater detailbelow, first vacuum opening (1174) and second vacuum opening (1176) areboth in communication with axial tube (1020) to supply vacuum to basket(1330) and the cutter of needle (1110).

Unlike the sealing member described in U.S. Pub. No. 2014/0039343,sealing member (1170) of the present aspect is comprised of asubstantially transparent material. It should be understood that in thepresent aspect sealing member (1170) is substantially transparent topermit an operator to see a tissue sample disposed within sealing member(1170). As will be described in greater detail below, this feature isusable in conjunction with a tissue analysis feature that will bedescribed in greater detail below. The term “substantially transparent”used herein should be understood to generally include a clear orsee-through sealing member (1170). However, it should be understood thatthe term “substantially transparent” should not necessarily be limitedto just being clear. For instance, in some aspects sealing member (1170)may include certain optical coatings that may have an impact on thetransparency of sealing member (1170) by limiting certain wavelengths oflight that penetrate sealing member (1170) to thereby enhancevisualization or analysis of a tissue sample.

Sample basket (1330) is best seen in FIG. 3. Basket (1330) is generallyconfigured to hold a plurality of tissue samples in a single tissuesample chamber (1346). As can be seen, basket (1330) comprises a grip(1332), a proximal wall (1334). Grip (1332) extends proximally fromproximal wall (1334) and is configured to be grasped by an operator tomanipulate basket (1330). Proximal wall (1334) defines a channel (1343)along the outer edge of the distal side of proximal wall (1334). Channel(1343) is configured to receive at least a portion of outer cover (1302)to fluidly seal the proximal end of tissue sample holder (1300) whenbasket (1330) is disposed in outer cover (1302). Although not shown, itshould be understood that channel (1343) can be equipped with gaskets orother sealing elements to further promote sealing between basket (1330)and outer cover (1302).

A pair of sidewalls (1344) and a lower floor (1340) extend distally fromproximal wall (1334). In the present aspect, sidewalk (1344) and lowerfloor (1340) are defined by a single semi-circular shaped member.However, it should be understood that in other aspects sidewalls (1344)and lower floor (1340) are more discretely defined by a square orrectangular cross-section. Regardless, an intermediate floor (1342) isdisposed above lower floor (1340). Lower floor (1340) and intermediatefloor (1342) are parallel relative to each other and are spacedlaterally from each other to define a vacuum passage (1349)therebetween. As will be described in greater detail below, vacuumpassage (1349) is configured to communicate vacuum through a pluralityof openings (1345) in intermediate floor (1342) to collect tissuesamples.

A distal wall (1336) extends upwardly from the distal end ofintermediate floor (1342). Distal wall (1336) further extends laterallyfrom sidewalls (1344). Distal wall (1336) of the present aspect definesa semi-circular shape that is configured to abut sample managementassembly (1310), as will be described in greater detail below. Distalwall (1336), proximal wall (1334), sidewalls (1344), and intermediatefloor (1342) together define a tissue sample chamber (1346). Tissuesample chamber (1346) is generally configured to receive a plurality oftissue samples therein. In the present aspect, tissue sample chamber(1346) is configured to receive anywhere between about 20 to about 50tissue samples. Of course, in other aspects tissue sample chamber (1346)may be configured to receive any other suitable number of tissuesamples.

An upper portion of distal wall (1336) includes a tissue opening (1338)therein. Furthermore, because distal wall (1336) terminates belowintermediate floor (1342), a vacuum opening (1347) is defined in thedistal end of basket (1330) between intermediate floor (1342) and lowerfloor (1340). As will be described in greater detail below, tissueopening (1338) is generally configured to be selectively placed intocommunication with cutter and axial tube (1020) via sample managementassembly (1310). Similarly, vacuum opening (1347) is generallyconfigured to be selectively placed into communication with axial tube(1020) via sample management assembly (1310). The selectivecommunication between tissue opening (1338) and vacuum opening (1347)generally permits tissue sample chamber (1346) to receive tissue samplestherein when such tissue samples are acquired via needle (1110) andtransported axially through the cutter.

Sample management assembly (1310) is shown in FIG. 4. As can be seen,sample management assembly (1310) comprises a first rotatable member(1312) and a second rotatable member (1322). First rotatable member(1312) comprises a generally coin shaped front screen body (1313). Frontscreen body (1313) defines an inner vacuum ring (1314) and an outertissue manipulation ring (1316). Inner vacuum ring (1314) comprises aplurality of vacuum openings (1315) extending through front screen body(1313) and 360° around the inside of front screen body (1313). As willbe described in greater detail below, vacuum openings (1315) aregenerally configured to communicate vacuum continuously from axial tube(1020) to the interior of the cutter disposed in needle (1110).

Outer tissue manipulation ring (1316) comprises an alternating array offilter portions (1318) and tissue openings (1317). In particular, eachfilter portion (1318) comprises an array of openings (1319) extendingthrough front screen body (1313) arranged in a pattern generallycorresponding to the outer diameter of the cutter disposed within needle(1110). As will be described in greater detail below, each filterportion (1318) is generally configured to prevent movement of a tissuesample through first rotatable member (1312), but permit the flow ofvacuum and/or fluid. By contrast, tissue opening (1317) comprises asingle opening extending through front screen body (1313) that isgenerally sized corresponding to the outer diameter of the cutterdisposed within needle (1110). Thus tissue opening (1317) is generallyconfigured to permit fluid, vacuum, and tissue samples to pass throughfront screen body (1313).

As described above, filter portions (1318) and tissue openings (1317)are arranged in an alternating ring shaped array about front screen body(1313). Each filter portion (1318) and tissue opening (1317) ispositioned equidistantly about front screen body (1313) near the outeredge of front screen body (1313). It should be understood that eachfilter portion (1318) and tissue opening (1317) extends through frontscreen body (1313) in a direction that is parallel to an axis ofrotation of front screen body (1313). Accordingly, as will be describedin greater detail below, rotation of front screen body (1313) isgenerally configured to result in a particular filter portion (1318) ortissue opening (1317) being indexed with tissue opening (1338) of tissuesample holder (1300). As will also be described in greater detail below,this alternating relationship of filter portions (1318) and tissuesopenings (1317) is generally configured to permit sample managementassembly (1310) to selectively block tissue samples from entering tissuesample holder (1300).

First rotatable member (1312) further comprises a central shaft (1320)and a pair of attachment features (1321). Central shaft (1320) issubstantially similar to the central shaft as described in U.S. Pub. No.2014/0039343 with respect to manifold. In particular, central shaft(1320) is configured to couple with a grasping feature (1184) of arotation member (1180) (FIG. 2) to provide rotation of first rotatablemember (1312) upon rotation of gear (1182). Of course, in other aspectsany other suitable features for rotating first rotatable member (1312)may be used as will be apparent to those of ordinary skill in the art inview of the teachings herein.

Attachment features (1321) of the present aspect comprise an indentationof opposing sides of first rotatable member (1312). Attachment features(1321) permit fastening of first rotatable member (1312) to secondrotatable member (1322). Thus, it should be understood that firstrotatable member (1312) and second rotatable member (1322) areconfigured to rotate together in response to rotation of central shaft(1320). Although not shown, it should be understood that attachmentfeatures (1321) may include other additional features such as clips,retainers, fasteners, and/or etc. to promote attachment between firstrotatable member (1312) and second rotatable member (1322).

Second rotatable member (1322), like first rotatable member (1312),comprises a generally coin shaped rear screen body (1323). Rear screenbody (1323) includes an array of alternating tissue receiving portions(1324) and fluid portions (1327). Tissue receiving portions (1324) aregenerally configured to direct fluid and tissue through rear screen body(1323). In particular, each tissue receiving portion (1324) comprises atissue opening (1325) and a plurality of vacuum openings (1326). Eachtissue opening (1325) extends through rear screen body (1323) andcorresponds in size to each tissue opening (1317) described above. Assimilarly described above with respect to tissue openings (1317), tissueopenings (1325) of second rotatable member (1322) are generally sized tocorrespond to the outer diameter of the cutter disposed in needle (1110)such each tissue opening (1317) is configured to receive a tissue sampletherethrough. As will be described in greater detail below, this permitsa tissue sample to pass through first rotatable member (1312), thenthrough second rotatable member (1322), before finally being depositedin tissue sample holder (1300).

Vacuum openings (1326) of each tissue receiving portion (1324) areconfigured to permit the flow of vacuum through rear screen body (1323)of second rotatable member (1322). As will be described in greaterdetail below, this permits vacuum and/or fluid to pass through secondrotatable member (1322) and into tissue sample holder (1300). Vacuum intissue sample holder (1300) is then transferred to the cutter disposedwithin needle (1110) via a respective tissue opening (1325).

Each fluid portion (1327) is generally configured to redirect fluid flowrelative to second rotatable member (1322), thereby blocking flow ofvacuum and/or fluid from entering tissue sample holder (1300). Inparticular, each fluid portion (1327) comprises a generallytrapezoidaily or tear drop-shaped recess (1328). The internal edges ofeach recess (1328) are rounded to promote fluid flow within each recess(1328). Of course, in other aspects the internal edges of each recess(1328) may be straight or include some other structural shape. Eachangled leg of the trapezoidal shape of each recess (1328) is angledradially with the circular cross-sectional shape of rear screen body(1323). As best seen in FIG. 5, the inner and narrower portion of eachrecess (1328) is configured to communicate with vacuum openings (1315)of first rotatable member (1312). The outer and wider portion of eachrecess (1328) is configured to communicate with openings (1319) of acorresponding filter portion (1318) in first rotatable member (1312).Thus, as will be described in greater detail below, each recess (1328)is configured to redirect vacuum and/or fluid from vacuum openings(1315) of first rotatable member (1312) to openings (1319) of acorresponding filter portion (1318) in first rotatable member (1312).

Like with first rotatable member (1312) described above, secondrotatable member (1322) likewise includes attachment features (1329) onopposing sides of rear screen body (1323). Like with attachment features(1321) described above, attachment features (1329) of the present aspectcomprise an indentation in rear screen body (1323). Each attachmentfeature (1329) is configured to engage with a corresponding attachmentfeature (1321) of first rotatable member (1312) to secure secondrotatable member (1322) to first rotatable member (1312). Thus, itshould be understood that first rotatable member (1312) and secondrotatable member (1322) are generally fixed together such that bothfirst rotatable member (1312) and second rotatable member (1322) rotatetogether upon rotation of central shaft (1320).

As can best be seen in FIG. 6, first rotatable member (1312) and secondrotatable member (1322) are generally configured to fasten together.When fastened together, vacuum ring (1314) of first rotatable member(1312) is in communication with recesses (1328) and vacuum openings(1326) of second rotatable member (1322). Accordingly, when vacuum iscommunicated through a particular portion of vacuum ring (1314) vacuumwill be communicated through vacuum openings (1315) of vacuum ring(1314) to either at a corresponding recess (1328) or array of vacuumopenings (1326) of second rotatable member (1322).

As can also be seen in FIG. 6, each tissue opening (1317) of firstrotatable member (1312) is in communication with a corresponding tissueopening (1325) of second rotatable member (1322). Likewise, each filterportion (1318) of first rotatable member (1312) is in communication witha corresponding recess (1328) of second rotatable member (1322). Thus,as first rotatable member (1312) alternates between filter portion(1318) and tissue opening (1317), there is a corresponding alternationbetween communication with a corresponding recess (1328) and tissueopening (1325) of second rotatable member (1322). As will be describedin greater detail below, this alternating relationship permits samplemanagement assembly (1310) to selectively enable and disablecommunication of tissue sample holder (1300) with the cutter disposedwithin needle (1110).

FIGS. 7-10 show an exemplary operation of sample management assembly(1310) to collect tissue samples in tissue sample holder (1300). Inparticular, as can be seen in FIGS. 7 and 8, sample management assembly(1310) initially begins in a sample blocking state. In the sampleblocking state, sample management assembly (1310) is rotated to alignfilter portion (1318) of first rotatable member (1312) with cutter seal(1172) of sealing member (1170). Because filter portion (1318) comprisesan array of vacuum openings (1319), tissue samples are generally blockedfrom entering tissue sample holder (1300) by filter portion (1318). Inaddition, while in the blocking state, vacuum ring (1314) of firstrotatable member (1312) is aligned with vacuum opening (1174) of sealingmember (1170), thereby permitting vacuum from axial tube (1020) to passthrough vacuum opening (1174) of sealing member (1170) and vacuumopenings (1315) in vacuum ring (1314) of first rotatable member (1312).

Also in the blocking state, second rotatable member (1322) is rotatedsuch that a recess (1328) corresponding to the given filter portion(1318) is aligned with cutter seal (1172) and vacuum opening (1174) ofsealing member (1170). Because vacuum opening (1174) is in communicationwith axial tube (1020), vacuum will be communicated through axial tube(1020), through vacuum openings (1315) of vacuum ling (1314), and intorecess (1328). Vacuum is then directed through recess (1328) to openings(1319) in filter portion (1318) of first rotatable member (1312) andinto cutter seal (1172) of sealing member (1170) before finally beingcommunicated to the cutter disposed in needle (1110). Thus, it should beunderstood that when sample management assembly (1310) is in the tissueblocking state, vacuum is directed through sample management assembly(1310) to the cutter without passing through tissue sample holder(1300).

When the cutter is used to collect a tissue sample while samplemanagement assembly (1310) is in the blocking state, the tissue sampleis transported through cutter to cutter seal (1172) of sealing member(1170) using vacuum that is redirected through recess (1328) of secondrotatable member (1322). Filter portion (1318) blocks further movementof the tissue sample, thereby maintaining the tissue sample withincutter seal (1172) of sealing member (1170). Because sealing member(1170) of the present aspect is generally transparent, the tissue samplecan be viewed and at least partially analyzed through tissue window(1103) in housing (1102) of probe (1100).

To communicate tissue samples to tissue sample holder (1300), samplemanagement assembly (1310) is rotated to a tissue transport position asshown in FIGS. 9 and 10. To transition sample management assembly (1310)to the tissue transport position, first rotatable member (1312) andsecond rotatable member (1322) are indexed to align the next adjacenttissue opening (1317, 1325) with the cutter disposed with needle (1110).In particular, as can be seen in FIG. 9, first rotatable member (1312)is rotated to align a given tissue opening (1317) with cutter seal(1172) of sealing member (1170). Vacuum ring (1314) remains aligned withfirst vacuum opening (1174) of sealing member (1170), but new openings(1315) are exposed due to rotation of first rotatable member (1312).Another tissue opening (1317) on the opposite side of first rotatablemember (1312) is also aligned with second vacuum opening (1176) ofcutter seal (1172).

As first rotatable member (1312) is rotated, second rotatable member(1322) is also rotated to index the next adjacent tissue opening (1325)with the cutter disposed in needle (1110) via sealing member (1170).Because tissue openings (1317, 1325) of first rotatable member (1312)and second rotatable member (1322) are indexed with the cutter disposedwithin needle (1110) via sealing member (1170) tissue samples severed bythe cutter can travel through tissue openings (1317, 1325) and intotissue sample chamber (1346) of tissue sample holder (1300). Inparticular, to communicate a tissue sample into tissue sample holder(1300), vacuum passes from axial tube (1020) into first and secondvacuum opening (1174, 1176) of sealing member (1170). Vacuum travelingthrough first vacuum opening (1174) of sealing member (1170) then iscommunicated through the vacuum openings (1315) in vacuum ring (1314) offirst rotatable member (1312) and vacuum openings (1326) in secondrotatable member (1322). From vacuum openings (1326) in second rotatablemember (1322), vacuum travels into tissue sample holder (1300) wherenegative pressure builds to induce vacuum through the tissue openings(1317, 1325) of first and second rotatable members (1312, 1322) that arein communication with cutter seal (1172) of sealing member (1170).

In addition to the vacuum path described above, vacuum traveling throughsecond vacuum opening (1176) of sealing member (1170) is communicatedthrough the tissue openings (1317, 1325) of first and second rotatablemembers (1312, 1322) that are in communication with second vacuumopening (1176). This vacuum is then directed through vacuum opening(1347) of basket (1330) and through vacuum passage (1349). Vacuum canthen travel upwardly through openings (1345) in intermediate floor(1342) of basket (1330). Such communication of vacuum throughintermediate floor (1342) may in some aspects direct tissue samplesdownwardly into the bottom of basket (1330). In addition, excess fluidscollected during a biopsy procedure may be evacuated from tissue sampleholder (300) through intermediate floor (1342).

Once a tissue sample has been collected in tissue sample holder (1300),sample management assembly (1310) may be rotated again to transitionback to the tissue blocking position described above. Because thevarious features of first rotatable member (1312) and second rotatablemember (1322) are disposed in an alternating configuration, it should beunderstood that sample management assembly (1310) may be rotated in anydirection to transition between the tissue blocking position and thetissue transport position. In some aspects, first rotatable member(1312) and second rotatable member (1322) are successively rotated in asingle direction to transition sample management assembly (1310) betweenthe tissue blocking position and the tissue transport position. Ofcourse, such a mode of operation is merely optional and in other aspectsfirst rotatable member (1312) and second rotatable member (1322) may berotated through any suitable sequence in any suitable direction.

In some circumstances it may be desirable to include within a biopsydevice other forms of tissue sample analysis in addition to or in lieuof the visual analysis described in U.S. Pub. No. 2014/0039343 withrespect to probe (1100). For instance, in some aspects bioimpedancesensors can be used to identify certain physical characteristics of atissue sample. For purposes of this patent application “bioimpedancesensors” are defined as “sensors that measure how mammalian tissueopposes a tiny applied alternating current”. In such aspects, sensorscan be positioned within a biopsy device to obtain impedancemeasurements of a given tissue sample. These impedance measurements canthen be compared to known impedance values of healthy and anomaloustissue to identify whether the given tissue sample might include anyanomalies (e.g., calcifications, etc.).

Exemplary probes utilizing bioimpedance for tissue sample analysis aredescribed below. It should be understood that the various alternativeprobes described below may be readily incorporated into the biopsydevice as described in U.S. Pub. No. 2014/0039343. It should also beunderstood that the various components and probe described above and/orin U.S. Pub. No. 2014/0039343 may be readily incorporated into thealternative probes described below. Various suitable ways in which theabove and below teachings may be combined will be apparent to those ofordinary skill in the art in view of the teachings herein. It shouldalso be understood that the following teachings may be readily combinedwith the various teachings of the references that are cited herein.

FIG. 11 shows an exemplary alternative probe (2100) that can be readilyincorporated into the biopsy device as described in U.S. Pub. No.2014/0039343. It should be understood that except as otherwise notedherein, probe (2100) is substantially the same as probe described inU.S. Pub. No. 2014/0039343. Unlike the probe in U.S. Pub. No.2014/0039343, probe (2100) of the present aspect is generally configuredto permit individual analysis of a tissue sample using another tissueanalysis feature that will be described in greater detail below. Probe(2100) is further configured to store tissue samples in a bulkconfiguration. As will be described in greater detail below, probe(2100) generally includes features to permit temporary isolation of asingle tissue sample followed by deposit in a single bulk tissue chamber(2346).

Probe (2100) of the present aspect includes a needle (2110) extendingdistally from probe (2100) that is inserted into a patient's tissue toobtain tissue samples. These tissue samples are deposited in a tissuesample holder (2300) at the proximal end of probe (2100). As similarlydescribed in U.S. Pub. No. 2014/0039343 with respect to the probe, thevacuum control module can be coupled with probe (2100) via a valveassembly and one or more tubes (2020), which is operable to selectivelyprovide vacuum, saline, atmospheric air, and venting to probe (2100).Probe (2100) also includes a top housing (2102) or body that generallydefines an exterior surface of probe (2100) for gripping by an operatorto manipulate needle (2110). Although not shown, it should be understoodthat probe (2100) includes gears or other feature similar to the gearsdescribed in U.S. Pub. No. 2014/0039343. As similarly described in U.S.Pub. No. 2014/0039343 with respect to the probe, such gears and/or otherfeatures are operable to drive a cutter actuation mechanism in probe(2100) to rotate and translate a cutter (not shown) disposed withinneedle (2110). Additionally, such gears and/or other features areoperable to drive tissue sample holder (2300) as will be described ingreater detail below.

Needle (2110) is substantially the same as the needle described aboveand/or in U.S. Pub. No. 2014/0039343. For instance, needle (2110) of thepresent aspect comprises a cannula (2113) having a piercing tip (2112),a lateral aperture (2114) located proximal to tip (2112). Although notshown, it should be understood that in some aspects needle (2110) alsoincludes a hub member (not shown) similar to the hub member described inU.S. Pub. No. 2014/0039343. As similarly described as the tip in U.S.Pub. No. 2014/0039343, tip (2112) of the present aspect is configured topierce and penetrate tissue, without requiring a high amount of force,and without requiring an opening to be pre-formed in tissue prior toinsertion of tip (2112).

Lateral aperture (2114) is also substantially similar to the lateralaperture described in U.S. Pub. No. 2014/0039343. For instance, lateralaperture (2114) is sized to receive prolapsed tissue during operation ofbiopsy device. Although not shown, it should be understood that a hollowtubular cutter (not shown) is disposed within needle. The cutter in thepresent aspect is substantially similar to the cutter described in U.S.Pub. No. 2014/0039343 such that the cutter is operable to rotate andtranslate relative to needle (2110) and past lateral aperture (2114) tosever a tissue sample from tissue protruding through lateral aperture(2114). Also as similarly described as the needle in U.S. Pub. No.2014/0039343, needle (2110) of the present aspect is configured to berotated about the longitudinal axis of needle (2110) to orient lateralaperture (2114) at any desired axial position.

As described above, probe (2100) includes housing (2102), which supportsthe internal components of probe (2100). Needle (2110) protrudesdistally from housing (2102) and is supported by housing (2102) suchthat an operator can manipulate needle (2110) by grasping housing(2102). Unlike the housing described in U.S. Pub. No. 2014/0039343,housing (2102) of the present aspect includes a tissue analysis portion(2103). As will be described in greater detail below, tissue analysisportion (2103) provides a tissue analysis feature that utilizesbioimpedance to analyze tissue samples. Additionally, in some aspects atleast a portion of tissue analysis portion (2103) may be transparent toprovide a means for individual tissues samples to be analyzed by visualinspection in addition to bioimpedance.

The proximal end of housing (2102) supports a tissue sample holder(2300) that is similar to the tissue sample holder described in U.S.Pub. No. 2014/0039343. However, unlike the tissue sample holderdescribed in U.S. Pub. No. 2014/0039343, tissue sample holder (2300) ofthe present aspect is configured to store tissue samples in a singlebulk tissue sample chamber (2346). As is best seen in FIG. 12, tissuesample holder (2300) comprises a sample basket (2330), a samplemanagement assembly (2310), and an outer cover (2302). Sample basket(2330) is substantially similar to the sample basket described in U.S.Pub. No. 2014/0039343. For instance, basket (2330) is generallyconfigured to hold a plurality of tissue samples in a single tissuesample chamber (2346). As can be seen, basket (2330) comprises a grip(2332) and a proximal wall (2334). Grip (2332) extends proximally fromproximal wall (2334) and is configured to be grasped by an operator tomanipulate basket (2330). Proximal wall (2334) defines a channel (2343)along the outer edge of the distal side of proximal wall (2334). Channel(2343) is configured to receive at least a portion of outer cover (2302)to fluidly seal the proximal end of tissue sample holder (2300) whenbasket (2330) is disposed in outer cover (2302). Although not shown, itshould be understood that channel (2343) can be equipped with gaskets orother sealing elements to further promote sealing between basket (2330)and outer cover (2302).

A pair of sidewalls (2344) and a lower floor (2340) extend distally fromproximal wall (2334). In the present aspect, sidewalls (2344) and lowerfloor (2340) are defined by a single semi-circular shaped member.However, it should be understood that in other aspects sidewalls (2334)and lower floor (2340) are more discretely defined by a square orrectangular cross-section. Regardless, an intermediate floor (2342) isdisposed above lower floor (2340). Lower floor (2340) and intermediatefloor (2342) are parallel relative to each other and are spacedlaterally from each other to define a vacuum passage (2349)therebetween. As will be described in greater detail below, vacuumpassage (2349) is configured to communicate vacuum through a pluralityof openings (2345) in intermediate floor (2342) to collect tissuesamples.

A distal wall (2336) extends upwardly from the distal end ofintermediate floor (2342). Distal wall (2336) further extends laterallyfrom sidewalls (2344). Distal wall (2336) of the present aspect definesa semi-circular shape that is configured to abut sample managementassembly (2310), as will be described in greater detail below. Distalwall (2336), proximal wall (2334), sidewalls (2344), and intermediatefloor (2342) together define a tissue sample chamber (2346). Tissuesample chamber (2346) is generally configured to receive a plurality oftissue samples therein. In the present aspect, tissue sample chamber(2346) is configured to receive anywhere between about 20 to about 50tissue samples. Of course, in other aspects tissue sample chamber (2346)may be configured to receive any other suitable number of tissuesamples.

An upper portion of distal wall (2336) includes a tissue opening (2338)therein. Furthermore, because distal wall (2336) terminates belowintermediate floor (2342), a vacuum opening (2347) is defined in thedistal end of basket (2330) between intermediate floor (2342) and lowerfloor (2340). As will be described in greater detail below, tissueopening (2338) is generally configured to be selectively placed intocommunication with cutter via sample management assembly (2310).Similarly, vacuum opening (2347) is generally configured to beselectively placed into communication with and tube (2020) via samplemanagement assembly (2310). The selective communication between tissueopening (2338) and vacuum opening (2347) generally permits tissue samplechamber (2346) to receive tissue samples therein when such tissuesamples are acquired via needle (2110) and transported axially throughthe cutter.

Outer cover (2302) is best seen in FIGS. 12-14. As can be seen, outercover (2302) is generally cylindrically shaped and is configured toreceive basket (2330) and sample management assembly (2310) through anopen proximal end (2303). On the distal end of outer cover (2302), avacuum port (2304) extends through outer cover (2302) to permitcommunication of vacuum into outer cover (2302) via tube (2020), as willbe described in greater detail below.

A sample analysis assembly (2305) extends distally from outer cover(2302). Sample analysis assembly (2305) is generally configured toanalyze individual tissue samples as they are collected by needle (2110)and the cutter disposed within needle (2110). Sample analysis assembly(2305) comprises a gear opening (2306), a cutter opening (2307) and twobioimpedance electrodes (2309). As will be described in greater detailbelow, gear opening (2306) extends through sample analysis assembly(2305) such that at least a portion of sample management assembly (2310)can extend out of outer cover (2302) and mechanically communicate withbiopsy device.

Cutter opening (2307) is in communication with a cutter passage (2308),which extends through sample analysis assembly (2305). Cutter passage(2308) is similar to the cutter seals described above and/or in U.S.Pub. No. 2014/0039343 with respect to sealing members described aboveand in U.S. Pub. No. 2014/0039343. For instance, cutter passage (2308)is configured to receive the cutter disposed within needle (2110)through the entire range of motion of the cutter such that there is asealed path between lateral aperture (2114) and the proximal end of thecutter. Additionally, in some instances, sample analysis assembly (2305)is constructed of a transparent material such that the interior ofcutter passage (2308) is visible to an operator for visual analysis ofindividual tissue samples.

The interior of cutter passage (2308) is best seen in 14. As can beseen, electrodes (2309) extend from the exterior of sample analysisassembly (2305) though sample analysis assembly (2305) such that atleast a portion of each electrode (2309) extends into the interior ofcutter passage (2308). In the present aspect, each electrode (2309) ispositioned inside cutter passage (2308) to make substantial physicalcontact with tissue samples as they pass through, or are present within,cutter passage (2308).

As will be described in greater detail below, electrodes (2309) aregenerally configured to couple with a biopsy device as described in U.S.Pub. No. 2014/0039343 via any suitable electrical coupling such that theimpedance of a given tissue sample may be measured. The measuredimpedance of a given tissue sample may then be analyzed via biopsydevice and/or control module to identify various properties of the giventissue sample (e.g., to detect calcifications and/or other anomalies).

In the present aspect, electrodes (2309) extend from cutter passage(2308) along the outer surface of tissue analysis assembly (2305) andaround the underside of gear opening (2306). Additionally, electrodes(2309) of the present aspect are partially inlaid into the outer surfaceof tissue analysis assembly (2305). In other aspects, electrodes (2309)may simply be secured to the outer surface of tissue analysis assembly(2305) without being inlaid into the surface at all. In still otheraspects, electrodes (2309) may be entirely embedded in the structure oftissue analysis assembly (2305).

Electrodes (2309) of the present aspect are exposed to the exterior oftissue analysis assembly (2305) to promote electrical connectivity withthe biopsy device. For instance, in some circumstances certain featuresof biopsy device include electrical contacts that correspond toelectrodes (2309) such that electrical contacts of electrodes (2309) maycommunicate with biopsy device when probe (2100) is connected to biopsydevice. To further promote electrical contact, it should be understoodthat in some aspects biopsy device or tissue analysis assembly (2305)may include various electrical connectivity features such as brushes,slip rings, and/or etc.

Regardless of particularly how electrodes (2309) achieve electricalcontinuity with biopsy device, it should be understood that ultimatelyimpedance information from collected tissue samples is communicated fromelectrodes (2309) to the biopsy device and/or control module. Thisinformation can then be used to provide real time analysis of collectedtissue samples. In merely one aspect, impedance information is used todetect the presence of cancerous cells in biopsy samples. Of course, anyother suitable use of impedance information can be used as will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Sample management assembly (2310) is shown in FIG. 15. As can be seen,sample management assembly (2310) comprises a rotatable member (2312).Rotatable member (2312) comprises a generally coin-shaped body (2313)with a rotation member (2320) extending distally from body (2313). Body(2313) defines a tissue manipulation ring (2314). Tissue manipulationring (2314) includes a filter portion (2316) and a transport portion(2318). Filter portion (2316) comprises a plurality of vacuum holes(2317) arranged in a ring-shaped pattern axially around body (2313).Vacuum holes (2317) together are configured to receive vacuum and fluidtherethrough, yet prevent the passage of tissue. By contrast, transportportion (2318) comprises a single opening (2319) that is sized toreceive tissue samples therethrough. Transport portion (2318) ispositioned along the same circular path as vacuum holes (2317) such thattransport portion (2318) interrupts at least a portion of filter portion(2316).

Both filter portion (2316) and transport portion (2318) are positioned adistance from the center of body (2313) such that filter portion (2316)or transport portion (2318) can align with cutter passage (2308) oftissue analysis assembly (2305). However, whether filter portion (2316)or transport portion (2318) is indexed with cutter passage (2308) oftissue analysis assembly (2305) depends on the rotational orientation ofrotatable member (2312). Thus, it should be understood that body (2313)is generally configured to selectively block or unblock transport oftissue samples to tissue sample chamber (2346) based on rotation ofrotatable member (2312).

Additionally, it should be understood that vacuum port (2304) of outercover (2302) is oriented an equal distance from the center of rotatablemember (2312) as cutter passage (2308). Thus, vacuum port (2304) iscontinuously in communication with tissue sample holder (2300) viaeither filter portion (2316) or transport portion (2318).

As described above, rotation member (2320) extends distally from body(2313). Rotation member (2320) includes a toothed portion (2321) on thedistal end thereof. When sample management assembly (2310) is disposedwithin outer cover (2302), rotation member (2320) extends through gearopening (2306) of tissue analysis assembly (2305) to permit mechanicalcommunication between toothed portion (2321) and corresponding gearsand/or other features of biopsy device. Thus, rotation member (2320) isconfigured to actuate sample management assembly (2310) via rotation ofrotation member (2320).

FIGS. 16-19 show an exemplary operation of a sample management assemblyto collect tissue samples in tissue sample holder (2300). In particular,as can be seen in FIGS. 16 and 17, sample management assembly (2310)initially begins in a sample blocking state. In the sample blockingstate, sample management assembly (2310) is rotated to align filterportion (2316) of rotatable member (2312) with cutter passage (2308) oftissue analysis assembly (2305). Because filter portion (2316) comprisesa plurality of vacuum openings (2317), tissue samples are generallyblocked from entering tissue sample holder (2300) by filter portion(2316). However, due to the presence and location of vacuum port (2304)of outer cover (2302), vacuum continuously communicates from tube (2020)to tissue sample holder (2300) via vacuum port (2304). Thus, when samplemanagement assembly (2310) is in the sample blocking state, vacuum cancommunicate to the cutter through vacuum port (2304) by way of vacuumpassage (2349) in basket (2330), openings (2345) in intermediate floor(2342), and openings (2317) in filter portion (2316).

When the cutter is used to collect a tissue sample while samplemanagement assembly (2310) is in the blocking state, the tissue sampleis transported through cutter to cutter passage (2308) of tissueanalysis assembly (2305) using vacuum from tube (2020) via vacuum port(2304). Filter portion (2316) blocks further movement of the tissuesample, thereby maintaining the tissue sample within cutter passage(2308) of tissue analysis assembly (2305). While the tissue sample isblocked from entering tissue sample chamber (2346) of tissue sampleholder (2300), the tissue sample may be analyzed using electrodes (2309)that protrude into cutter passage (2308). In the present aspect,impedance related data is collected to detect the presence of cancerand/or other tissue anomalies. Sample management assembly (2310) mayremain in the blocked state for the duration of the sample analysisprocedure. In aspects where tissue analysis assembly (2305) comprises atransparent material, the tissue sample may additionally be visuallyanalyzed during this time.

To communicate tissue samples to tissue sample holder (2300), samplemanagement assembly (2310) is rotated to a tissue transport position asshown in FIGS. 18 and 19. To transition sample management assembly(2310) to the tissue transport position, rotatable member (2312) isindexed to align transport portion (2318) with cutter passage (2308). Inparticular, as can be seen in FIG. 19, rotatable member (2112) isrotated to align opening (2319) of transport portion (2318) with cutterpassage (2308). With opening (2319) of transport portion (2318) alignedwith cutter passage (2308), tissue samples may freely pass throughsample management assembly (2310) where they are deposited in tissuesample chamber (2346) under the influence of vacuum communicated fromtube (2020) via port (2304) in outer cover (2302)

Once a tissue sample has been collected in tissue sample holder (2300),sample management assembly (2310) may be rotated again to transitionback to the tissue blocking position described above. It should beunderstood that sample management assembly (2310) may be rotated in anydirection to transition between the tissue blocking position and thetissue transport position. Additionally, the procedure for collecting asample, analyzing the sample, and then transporting to tissue sampleholder (2300) may be repeated as desired by the operator until theconclusion of the biopsy procedure, or until tissue sample chamber(2346) is filled to capacity with tissue samples. Where tissue samplechamber (2346) is filled to capacity, basket (2330) may be removed fromouter cover (2302) and either is emptied and reinserted, or replacedwith an entirely new basket (2330). While tissue analysis assembly(2305) is described herein as being usable in connection with samplemanagement assembly (2310), it should be understood that no suchlimitation is intended. For instance, in some aspects sample analysisassembly (2305) may be readily usable with sample management assembly(1310) described above or any other sample management assembly describedherein. Of course, various other methods and/or procedures may be usedas will be apparent to those of ordinary skill in the art in view of theteachings herein.

FIG. 20 depicts an alternative rotatable member (2512) that may bereadily incorporated into sample management assembly (2310) described inabove, or any other sample management assembly described herein.Rotatable member (2512) is substantially the same as rotatable member(2312) described above, except that a pivot screen body (2513) ofrotatable member (2512) extends for only a portion of a circle insteadof a complete circle. In particular, rotatable member (2512) of thepresent aspect comprises pivot screen body (2513) and a rotation member(2520) extending distally from pivot screen body (2513). Rotation member(2520) comprises a toothed portion (2521) and is substantially the sameas rotation member (2320) described above such that rotation member(2520) will not be described in further detail herein.

Pivot screen body (2513) comprises a generally triangularcross-sectional shape extending radially outwardly from the axial centerof rotation ember (2520). Pivot screen body (2513) comprises a filterband (2516) disposed near the outer edge of pivot screen body (2513).Filter band (2516) is substantially similar to filter portion (2316)described above with respect to rotatable member (2312), except filterband (2516) only extends for a fraction of an angular distance relativeto filter portion (2316). As with filter portion (2316), filter band(2516) comprises a plurality of openings (2517) that are configured topermit the flow of vacuum and fluid, but prevent the flow of tissuesamples. Accordingly, rotatable member (2512) is configured tosubstantially prevent flow of tissue samples to tissue sample holder(2300) when filter band (2516) is aligned with cutter passage (2308) ofsample analysis assembly (2305).

In use, rotatable member (2512) functions as similarly described abovewith respect to rotatable member (2312). For instance, rotatable member(2512) is rotated via rotation member (2520) to align filter band (2516)with cutter passage (2307) of sample analysis assembly (2305) to placesample management assembly (2310) in a tissue blocking state. However,because rotatable member (2512) omits structures similar to transportportion (2318) of rotatable member (2312), rotatable member (2512) isonly rotated out of alignment with cutter passage (2307) to permittransport of tissue samples to tissue sample holder (2300), and therebytransition sample management assembly (2310) to a transport state.

As noted above, in some instances it may be desirable to collect tissuesamples in a single bulk chamber. However, when tissue samples arecollected in bulk it may still be desirable to perform at least sometissue analysis as each tissue sample is collected. Thus, alternativeconfigurations may be desirable to perform analysis of individual tissuesamples in real time during a breast biopsy procedure.

In addition, in some instances tissue samples may exhibit the tendencyto stick or adhere to various surfaces of tissue sample holders similarto the tissue sample holder described above and/or in U.S. Pub. No.2014/0039343. Thus, in some aspects it may be desirable to includefeatures for manipulation of tissue that overcome the tendency of tissuesamples to stick and/or adhere to surfaces of the tissue sample holder.Various alternative sample management assemblies are described below.Such alternative sample management assemblies are constructed to includefeatures for bulk storage of tissue samples and individual tissue sampleanalysis. Additionally, such alternative sample management assembliesare constructed to include features to manipulate tissue samples toovercome issues associated with the tissue properties described aboveand/or in U.S. Pub. No. 2011/0039343.

It should be understood that the various alternative tissue managementassemblies described below may be readily incorporated into biopsydevice and any one of the probes described above and/or in U.S. Pub. No.2014/0039343. It should also be understood that the various componentsof the probes described above and/or in U.S. Pub. No. 2014/0039343 maybe readily incorporated into the alternative sample managementassemblies described below. Various suitable ways in which the above andbelow teachings may be combined will be apparent to those of ordinaryskill in the art in view of the teachings herein. It should also beunderstood that the below teachings may be readily combined with thevarious teachings of the references that are cited herein.

FIGS. 21-22 show an alternative sample management assembly (3310) thatmay be readily incorporated into any of the probes described aboveand/or in U.S. Pub. No. 2014/0039343. Sample management assembly (3310)is incorporated into a tissue sample holder (3300) that is substantiallysimilar to tissue sample holders described above and/or in U.S. Pub. No.2014/0039343. It should be understood that unless otherwise specificallynoted herein, tissue sample holder (3300) is identical to tissue sampleholders described above and/or in U.S. Pub. No. 2014/0039343. Forinstance, tissue sample holder (3300) of the present aspect isconfigured to store tissue samples in a single bulk tissue samplechamber (3346). As is best seen in FIG. 22, tissue sample holder (3300)comprises a sample basket (3330), a sample management assembly (3310),and an outer cover (3302).

Sample basket (3330) is substantially similar to sample baskets (1330,2330) described above and/or in U.S. Pub. No. 2014/0039343. Forinstance, basket (3330) is generally configured to hold a plurality oftissue samples in a single tissue sample chamber (3346). As can be seen,basket (3330) comprises a grip (3332) and a proximal wall (3334). Grip(3332) extends proximally from proximal wall (3334) and is configured tobe grasped by an operator to manipulate basket (3330). As will bedescribed in greater detail below, grip (3332) of the present aspect isadditionally configured to provide a fluid channeling function. Proximalwall (3334) defines a channel (not shown) along the outer edge of thedistal side of proximal wall (3334). The channel is configured toreceive at least a portion of outer cover (3302) to fluidly seal theproximal end of tissue sample holder (3300) when basket (3330) isdisposed in outer cover (3302). Although not shown, it should beunderstood that the channel can be equipped with gaskets or othersealing elements to further promote sealing between basket (3330) andouter cover (3302).

A pair of sidewalls (3344) and a lower floor (3340) extend distally fromproximal wall (3334). In the present aspect, sidewalls (3344) and lowerfloor (3340) are defined by a single semi-circular shaped member.However, it should be understood that in other aspects sidewalls (3334)and lower floor (3340) are more discretely defined by a square orrectangular cross-section. Although not shown, it should be understoodthat basket (3330) of the present aspect includes an intermediate floor(not shown) disposed above lower floor (3340) as similarly describedabove with respect to baskets (1330, 2330).

A distal wall (3336) is disposed at the distal end of basket (3330).Distal wall (3336) of the present aspect defines a semi-circular shapethat is configured to receive at least a portion of sample managementassembly (3310), as will be described in greater detail below. Distalwall (3336), proximal wall (3334), sidewalls (3344), and theintermediate floor together define a tissue sample chamber (3346).Tissue sample chamber (3346) is generally configured to receive aplurality of tissue samples therein. In the present aspect, tissuesample chamber (3346) is configured to receive anywhere between about 20to about 50 tissue samples. Of course, in other aspects tissue samplechamber (3346) may be configured to receive any other suitable number oftissue samples.

Outer cover (3302) of the present aspect is substantially similar toouter covers (1302, 2302) described above. For instance, outer cover(3302) of the present aspect comprises a generally hollow cylindricalshape that is configured to receive basket (3330) and sample managementassembly (3310). However, unlike outer covers (1302, 2302) describedabove, outer cover (3302) of the present aspect is connected directly totube (3020) to supply vacuum directly to outer cover (3302). Althoughouter cover (3302) of the present aspect is shown as connecting directlyto tube (3020), it should be understood that no such limitation isintended. For instance, in some aspects tube (3020) is connected toouter cover (3302) and the rest of tissue sample holder (3300) assimilarly described above with respect to tissue sample holders (1300,2300).

Sample management assembly (3310) is best seen in FIG. 23. As can beseen, sample management assembly (3310) generally comprises a samplereceiving portion (3312) and a drive portion (3320) extending proximallyfrom sample receiving portion (3312). Sample receiving portion (3312)has a shape that is generally characterized by a triangular prism with arounded top to that corresponds to the cylindrical shape of outer cover(3302). Sample receiving portion (3312) of the present aspect comprisesa substantially transparent material. The transparency of samplereceiving portion (3312) is generally sufficient to permit visualanalysis of tissue samples received therein.

Sample receiving portion (312) includes two sample chambers (3314, 3316)positioned adjacent to each other. Each sample chamber (3314, 3316)extends longitudinally through sample receiving portion (3312) from endto end such that each sample chamber (3314, 3316) is open on theproximal and distal ends of sample receiving portion (3312). Thelongitudinal extension of each sample chamber (3314, 3316) is generallyalong an axis that is parallel to a longitudinal axis of the cutter ofany one or more of probes described above and/or in U.S. Pub. No.2014/0039343. Additionally, the longitudinal extension of each samplechamber (3314, 3316) is generally parallel but offset relative to arotation axis defined by drive portion (3320).

Each sample chamber (3314, 3316) is generally configured to receive asingle tissue sample therein. As will be described in greater detailbelow, each sample chamber (3314, 3316) is generally positioned toselectively align with the cutter of one or more of probes describedabove and/or in U.S. Pub. No. 2014/0039343 when sample receiving portion(3312) is rotated via drive portion (3320). When a selected chamber(3314, 3316) is aligned with the cutter of any one or more of previouslydescribed probes, the non-aligned chamber (3316, 3314) acts as a vacuumpassage such that fluid first passes through the cutter and into theselected chamber (3314, 3316) before passing into the non-alignedchamber (3316, 3314). As will also be described in greater detail below,passage of fluid in this manner is facilitated by fluid channelingfeatures of grip (3332) of sample basket (3330).

It should be understood that any one of probes used in the presentaspect and/or in U.S. Pub. No. 2014/0039343 are capable of beingmodified for use with sample management assembly (3310). For instance,as can be seen in FIG. 24, sample receiving portion (3312) is generallydisposed proximally from the proximal end of any one of probes. Toaccommodate this positioning while maintaining communication with thecutter of a given probe, the particular probe used includes an extensionmember, tube, cannula, or device extending proximally from the proximalend of the probe. As will be described in greater detail below, thisconfiguration permits sample receiving portion (3312) to eject a tissuesample distally out of a given sample chamber (3314, 3316).

Drive portion (3320) generally comprises a cylindrical shaft (3321) anda gear portion (3322). Shaft (3321) extends distally from samplereceiving portion (3312) and is of integral construction therewith. Gearportion (3322) is disposed on the distal end of shaft (3321). Gearportion (3322) is generally configured to interact with correspondingcomponents of biopsy device to permit selective rotation of samplemanagement assembly (3310) about a rotation axis defied by the distalextension of cylindrical shaft (3321). As will be described in greaterdetail below, this selective rotation of sample management assembly(3310) permits each chamber (3314, 3316) of sample receiving portion(3312) to be indexed into communication of the cutter of any one or moreof probes described above and/or in U.S. Pub. No. 2014/0039343.

FIGS. 24-27 show an exemplary operation of sample management assembly(3310) to deposit a plurality of tissue samples into sample basket(3330). In particular, as can be seen in FIGS. 24 and 25, samplemanagement assembly (3310) is initially rotated into position relativeto any one or more of probes to align sample chamber (3316) with thecutter. As described above and/or in U.S. Pub. No. 2014/0039343,rotation of sample management assembly (3310) is achieved via driveportion (3320), which is actuated by certain drive components of biopsydevice.

One sample chamber (3316) is aligned as shown in FIG. 24, samplemanagement assembly (3310) is configured to receive a first tissuesample. In particular, to receive the first tissue sample, the firsttissue sample is severed using the cutter of any one or more of probesas described above and/or in U.S. Pub. No. 2014/0039343. Vacuum isapplied to tube (3020) to initiate transport of the first tissue samplethrough the cutter and into sample chamber (3316). During this process,vacuum passes through tube (3020) and into sample basket (3330). Once insample basket (3330), vacuum passes into chamber (3314). Vacuum is thencommunicated from chamber (3314) to chamber (3316) via a fluid passage(3333) defined by grip (3332) of sample basket (3330). Finally, vacuumpasses through sample chamber (3316) to the cutter. Thus, it should beunderstood that sample chambers (3314, 3316) and fluid passage (3333)collectively define a fluid passage from tube (3020) to the cutter asillustrated with arrows in FIG. 24.

Once the first tissue sample is received in sample chamber (3316), theoperator can analyze the first tissue sample by visually inspecting thesample through the transparency of sample receiving portion (3312) andthe transparency of outer cup (3302). Additionally, it should beunderstood that in some aspects sample chambers (3314, 3316) areequipped with sensors such as bioimpedance sensors similar to thosedescribed above with respect to probe (2100). In still other aspects,sample chambers (3314, 3316) are equipped with any other suitable sampleanalysis feature as will be apparent to those of ordinary skill in theart in view of the teachings herein.

Once an operator has sufficiently analyzed the first tissue samplereceived in sample chamber (3316), sample management assembly (3310) maybe next reconfigured to receive a second tissue sample. As is best seenin FIGS. 26 and 27, sample management assembly (3310) is reconfigured toreceive the second tissue sample by rotating sample management assembly(3310) via drive portion (3320). This rotation aligns sample chamber(3314) with the cutter of any one or more of the probes described above.Thus, sample receiving portion (3312) is positioned such that the secondtissue sample may be received in sample chamber (3314).

To receive the second tissue sample, vacuum is again applied to tube(3020) to transport the second tissue sample through the cutter and intosample chamber (3314). This involves a pneumatic circuit that issubstantially similar to the pneumatic circuit described above withrespect to FIG. 24. However, unlike the pneumatic circuit describedabove, in the present configuration, vacuum travels along an oppositepath. In particular, once vacuum is applied to sample basket (3330),vacuum passes into chamber (3316). Vacuum is then communicated fromchamber (3316) to chamber (3314) via fluid passage (3333) defined bygrip (3332) of sample basket (3330). Finally, vacuum passes throughsample chamber (3314) to the cutter. Because sample chamber (3316) isalready occupied by a tissue sample, it should be understood that thepresent pneumatic circuit has a dual purpose of both receiving thesecond tissue sample in sample chamber (3314) and ejecting the firsttissue sample from sample chamber (3314) (as illustrated by arrow B inFIG. 26). Thus, when sample chamber (3314) receives the second tissuesample, the first tissue sample is substantially simultaneously ejectedfrom sample chamber (3316). It should be understood that when the firsttissue sample is ejected from sample chamber (3316), the first tissuesample is deposited in sample basket (3330) for storage untilcompetition of the biopsy procedure or until sample basket (3330) isemptied.

One the second tissue sample is received in sample chamber (3314), thesecond tissue sample may be analyzed as similarly discussed above withrespect to the first tissue sample. At the conclusion of tissueanalysis, a subsequent tissue sample may be collected by returningsample management assembly (3310) to the configuration shown in FIGS. 24and 25. Further tissue samples may then be acquired and analyzed byrepeating the procedure described above. Thus, a plurality of tissuesamples are acquired and analyzed by alternating sample managementassembly (3310) between the configurations shown in FIGS. 24 and 25, andFIGS. 26 and 27. This process may be used by an operator until a desirednumber of tissue samples are acquired and analyzed.

In some instances challenges with manipulating tissue sample may beencountered. For aspect, generally moist tissue samples may sometimesexhibit an attraction to relatively dry surfaces within components ofbiopsy device or other components described herein. In other words,tissue samples may sometimes be sticky or tacky. Accordingly, in somedevices it may be desirable to include mechanisms that are suitable formanipulating tissue while overcoming the attraction that is sometimesencountered with tissue samples.

FIGS. 16-18 show an exemplary alternative tissue sample holder (4300)that may be readily incorporated into any of the probes described above.Tissue sample holder (4300) includes a sample management assembly (4310)that is generally configured to provide individual tissue sampleanalysis while overcoming certain difficulties associated withmanipulating tissue samples that have the tendency to stick to surfaceswithin tissue sample holder (4300). It should be understood that unlessotherwise specifically noted herein, tissue sample holder (4300) isidentical to tissue sample holders (1300, 2300, 3300) described above.For instance, tissue sample holder (4300) of the present aspect isconfigured to store tissue samples in a single bulk sample chamber(4346). As is best seen in FIG. 29, tissue sample holder (4300)comprises a rotation member (4180), a sealing member (4170), a samplebasket (1330), a sample management assembly (1310), and an outer cover(4302). Rotation member (4180) is substantially the same as rotationmember described in U.S. Pub. No. 2014/0039343 except rotation member(4180) of the present aspect includes a second gear (4184) in the placeof grasping feature (184) described in U.S. Pub. No. 2014/0039343. Aswill be described in greater detail below, second gear (4184) isgenerally configured to drive various components of sample managementassembly (4310) when a first gear (4182) of rotation member (4170) isacted upon by biopsy device. Sealing member (1170) of the present aspectis substantially the same as sealing members described in U.S. Pub. No.2014/0039343, such that further details of sealing member (1170) willnot be described herein.

Sample basket (4330) is substantially similar to sample baskets (1330,2330, 3330) described above. For instance, basket (4330) is generallyconfigured to hold a plurality of tissue samples in a single samplechamber (4346). As can be seen, basket (4330) comprises a grip (4332)and a proximal wall (4334). Grip (4332) extends proximally from proximalwall (4334) and is configured to be grasped by an operator to manipulatebasket (4330). Proximal wall (4334) is configured to seal with the innerdiameter of outer cover (4302) along the outer edge of proximal wall(4334). Thus, it should be understood that in some aspects the outeredge of proximal wall (4334) may include certain sealing features suchas gaskets, sealing members, channels, and/or etc. Proximal wall (4334)further includes a shaft opening (4343) extending through at least aportion of proximal wall (4334). Shaft opening (4343) of the presentaspect comprises a counterbore extending through only a portion ofproximal wall (4334). It should be understood that in other aspects,shaft opening (4343) alternatively extends through the entire thicknessof proximal wall (4334). As will be described in greater detail below,shaft opening (4343) is generally positioned and configured to supportvarious components of sample management assembly (4310).

A pair of sidewalls (4344) and a lower floor (4340) extend distally fromproximal wall (4334). In the present aspect, sidewalls (4344) and lowerfloor (4340) are defined by a single semi-circular shaped member.However, it should be understood that in other aspects sidewalls (4334)and lower floor (4340) are more discretely defined by a square orrectangular cross-section. Although not shown, it should be understoodthat in some aspects basket (4330) additionally includes an intermediatefloor (not shown) or other vacuum control features disposed above lowerfloor (4340) as similarly described above and/or in U.S. Pub. No.2014/0039343 with respect to baskets (1330, 2330). Where such anintermediate floor is incorporated into basket (4330), it should beunderstood that such aspects may include vent openings or other featuresto direct the flow of fluid through basket (4330).

A distal wall (4336) is disposed at the distal end of basket (4330).Distal wall (3336) of the present aspect defines a semi-circular shapethat is configured to receive at least a portion of sample managementassembly (4310), as will be described in greater detail below. Distalwall (4336), proximal wall (4334), sidewalls (4344), and theintermediate floor together define a tissue sample chamber (4346).Tissue sample chamber (4346) is generally configured to receive aplurality of tissue samples therein.

In one aspect, tissue sample chamber (4346) is configured to receiveanywhere from about 1 to about 50 tissue samples. In another aspect,tissue sample chamber (4346) is configured to receive anywhere fromabout 10 to about 50 tissue samples. In one aspect, tissue samplechamber (4346) is configured to receive anywhere from about 20 to about50 tissue samples. In one aspect, tissue sample chamber (4346) isconfigured to receive anywhere from about 25 to about 50 tissue samples.

Outer cover (4302) of the present aspect is substantially similar to theouter covers described above. For instance, outer cover (4302) of thepresent aspect comprises a generally hollow cylindrical shape that isconfigured to receive basket (4330) and sample management assembly(4310). However, unlike outer covers (1302, 2302, 3302) described above,outer cover (4302) of the present aspect includes certain features thatare configured to engage or support the operation of sample managementassembly (4310). For instance, as can best be seen in FIGS. 32 and 33,outer cover (4302) includes a distal wall (4303) that is disposedproximally of the distal end of outer cover (4302). Distal wall (4303)includes a cutter bore (4304), a shaft opening (4305), and a shall pin(4306). Cutter bore (4304) is configured to communicate with the cutterof any one of probes described above and/or in U.S. Pub. No.2014/0039343 via sealing member (4170). Thus, cutter bore (4304)provides an opening that permits tissue samples to pass through distalwall (4303) for manipulation via sample management assembly (4310).Although not shown, it should be understood that in some aspects cutterbore (4304) includes features that are configured to promote sealingbetween cutter bore (4304) and sealing member (4170).

Shaft opening (4305) extends entirely through distal wall (4303). Shaftopening (4305) is generally comprises a circular shape that isconfigured to provide an opening for at least a portion of certain drivecomponents of sample management assembly (4310) to pass through distalwall (4303). As will be described in greater detail below, this featureof distal wall (4303) permits rotational force to be communicatedthrough distal wall (4303) to drive various components of samplemanagement assembly (4310).

Shaft pin (4306) generally comprises a cylindrical protrusion extendingdistally from distal wall (4303). Like with shaft opening (4305)described above, shaft pin (4306) is generally associated with certaindrive components of sample management assembly (4310). As will bedescribed in greater detail below, shaft pin (4306) provides amechanical ground for certain drive components of sample managementassembly (4310) to rotatably attach to. Shaft opening (4305) and shaftpin (4306) are generally spaced from each other to support such anarrangement.

FIGS. 32 and 33 show the interior of outer cover (4302). As can be seen,the interior of outer cover (4302) includes a first rotation lock (4307)and a second rotation lock (4309). Each rotation lock (4307, 4309) isgenerally configured to engage a portion of sample management assembly(4310). As will be described in greater detail below, such engagementprevents rotation of certain components of sample management assembly(4310) so that sample management assembly (4310) can manipulate tissuesamples. In accordance with this purpose, first rotation lock (4307)includes a protrusion (4308) that is generally configured to correspondcertain geometric features of sample management assembly (4310) as willbe described in greater detail below.

As can best be seen in FIG. 33, each rotation lock (4307, 4309) extendsproximally from distal wall (4303) through almost the entire length ofouter cover (4302) with each rotation lock (4307, 4309) terminating justdistally of the proximal end of outer cover (4302). Additionally, eachrotation lock (4307, 4309) extends inwardly from the inner diameter ofouter cover (4302). As will be described in greater detail below, thisproximal and inward extension of each rotation lock (4307, 4309) isconfigured to permit each rotation lock (4307, 4309) to engage certaingeometric features of sample management assembly (4310).

Sample management assembly (4310) is best seen in FIG. 34. As can beseen, sample management assembly (4310) includes a series of alternatingcam plates (4312, 4320). Generally, sample management assembly (1310)comprises a plurality of rotational cam plates (4312), and a pluralityof stationary cam plates (4320). In the present aspect, each cam plate(4312, 4320) of a given type is generally identical to the other camplates (4312, 4320) of the same type. Thus, sample management assembly(4310) of the present aspect is comprised of two distinct cam plates(4312, 4320) that repeat in an alternating fashion. Although only twodistinct cam plates (4312, 4320) are used in the present aspect, itshould be understood that in other aspects a number of different camplates (4312, 4320) are incorporated into sample management assembly(4310) without departing from the functionality described below. All ofthe cam plates (1312, 4320) are connected axially via a drive shaft(4316). As will be described in greater detail below, drive shaft (4316)is generally configured to rotate rotational cam plates (1312) whilestationary cam plates (1320) remain fixed within outer cover (4302).

A single rotational cam plate (4312) is shown in FIG. 35. As can beseen, rotational cam plate (4312) generally comprises a cylindrical orcoin-shaped configuration. Rotational cam plate (4312) includes a tissueopening (4313) and a shaft opening (4314). Tissue opening (4313)comprises a U-shaped opening. As will be described in greater detailbelow, each tissue opening (4313) of each rotational cam plate (4312)aligns to collectively define a tissue manipulation feature (4319).Thus, each tissue opening (4313) is generally sized to receive a singletissue sample. Alternatively, in other aspects, each tissue opening(4313) is sized to receive multiple tissue samples while still retainingthe same functionality described in greater detail below.

Shaft opening (4314) comprises a generally circular shape with flats(4315) on adjacent sides of shaft opening (4314). As will be describedin greater detail below, shaft opening (4314) is configured tocorrespond to the shape of the outer diameter of drive shaft (4316).Accordingly, it should be understood that shaft opening (4314) isconfigured to mate with drive shaft (4316). Additionally, because of thepresence of flats (4315), shaft opening (4314) is configured to engagedrive shaft (4316) such that rotation of drive shaft results in rotationof rotational cam plate (4312). It should be understood that while shaftopening (4314) is shown as having a specific geometry, any othersuitable irregular geometry may be used. For instance, in some aspectsshaft opening (4314) is configured with a starburst pattern that isconfigured to engage corresponding splines on the exterior of driveshaft (4316). Similarly, in other aspects shaft opening (4314) isconfigured with a keyway that is configured to engage a correspondingkey protruding from the exterior of drive shaft (4316). Of course, anyother suitable geometry of shaft opening (4314) may be used as will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Stationary cam plate (4320) is best seen in FIG. 36. As can be seen,stationary cam plate (4320) comprises a camming portion (4322), alocking portion (4324), and a shaft opening (4329). Camming portion(4322) extends about 275° around the outer circumference of cam plate(4320) before transitioning to locking portion (4324). In other aspects,the particular amount of the outer circumference of cam plate (4320)through which camming portion (4322) extends may be anywhere betweenabout 270° to about 330°. Camming portion (4322) progressively extendsoutwardly as camming portion (4322) extends around the outercircumference of cam plate (4320). In other words, as camming portion(4322) extends in a clockwise direction around the outer circumferenceof cam plate (4320) the radius of cam plate (4320) increases. As will bedescribed in greater detail below, camming portion (4322) causes theeffective size of tissue opening (4313) of rotational cam plate (4312)to decrease as each rotational cam plate (4312) is rotated relative toeach stationary cam plate (4320). At the largest radius of cammingportion (4322), stationary cam plate (4320) has a radius that issubstantially equivalent to the radius of tissue opening (4313) ofrotational cam plate (4312) such that the effective size of tissueopening (4313) will be substantially zero when aligned with the largestradius of camming portion (4322).

Locking portion (4324) extends outwardly from the center of rotationalcam plate (4320) to a radius that is approximately equivalent to theinner radius of outer cover (4302). Locking portion (4324) of thepresent aspect includes a first lock opening (4326) and a second lockopening (4328). Lock openings (4326, 4328) are generally configured toreceive rotation locks (4307, 4309) of outer cover. In particular, firstlock opening (4326) is configured to receive protrusion (4308) of firstrotation lock (4307). Additionally, first lock opening (4326) extendsinwardly from a flat portion (4327) of locking portion (4324) such thatflat portion (4327) abuts first rotation lock (4307). Similarly, secondlock opening (4328) is configured to receive second rotational lock(4309) of outer cover (4302). Engagement between lock openings (4326,4328) and rotation locks (4307, 4309) maintains locking portion (4324)in a stationary position. As will be described in greater detail below,this feature permits rotational cam plate (4312) to rotate relative tostationary cam plate (4320) to manipulate a tissue sample.

Shaft opening (4329) of stationary cam plate (1320) is generallycircular in shape. Like shaft opening (4314) described above withrespect to rotational cam plate (1312), shaft opening (4329) ofstationary cam plate (4320) is configured to receive drive shaft (4316).However, because shaft opening (4329) of stationary cam plate (4320) iscircular in shape and omits features similar to flats (4315), driveshaft (4316) freely rotates relative to shaft opening (4329). Becauseeach stationary cam plate (4320) is generally fixed relative to outercover (4302), it should be understood that each stationary cam plate(4320) generally acts to stabilize drive shaft (4316) as drive shaft isrotated within shaft opening (4329) thereby maintaining the axialposition of drive shaft (4316).

FIG. 37 shows a partial view of drive shaft (4316) with some cam plates(4312, 4320) attached to drive shaft (4316) and some cam plates (4312,4320) removed from drive shaft (4316). As can be seen, drive shaft(4316) comprises a generally cylindrical structure that extends througha length greater than the combined length of the combination of camplates (4312, 4320). The generally cylindrical shape of drive shaft(4316) is circumscribed on two sides of drive shaft (4316) by a pair offlats (4317). Flats (4317) are generally configured to key withcorresponding flats (4315) of shaft openings (4314) of each rotationalcam plate (4312). Thus, drive shaft (4316) is configured to communicatetorque to each rotational cam plate (4312) to thereby rotate eachrotational cam plate (4312).

Drive shaft (4316) further includes a gear 4318) integrally formed inthe distal end of drive shaft (4316). Gear (4318) is configured toengage with rotation member (4180) to transfer rotational force frombiopsy device to drive shaft (4316). As can be seen in FIG. 38, whensample management assembly (4310) is fully assembled within outer cover(4302), drive shaft (4316) protrudes distally through shaft opening(4305) of distal wall (4303) of outer cover (4302). Rotation member(4180) is correspondingly rotationally mounted on pin (4306) of outercover (4302) such that rotation member (4180) is rotatable relative toouter cover (4302). Rotation member (4180) is thereby positioned toengage gear (4318) of drive shaft (4316) to rotate drive shaft (4316)relative to outer cover (4302).

FIG. 39 shows sample management assembly (4310) fully assembled in outercover (4302) from an opposite direction relative to the view shown inFIG. 38. As can be seen, when sample management assembly (4310) isdisposed within outer cover (4302), each stationary cam plate (4320) isheld in position by rotation locks (4307, 4309) of outer cover (4302).Stationary cam plates (4320) correspondingly maintain the axial positionof drive shaft (4316) such that drive shaft (4316) is aligned with shaftopening (4305) of outer cover (4302). Rotational cam plates (4312) arecorrespondingly held in position by drive shaft (4316) such that eachtissue opening (4313) is configured to align with cutter bore (4304) ofouter cover (4302) (provided that rotational cam plates (4312) arerotated into the position shown in FIG. 39).

FIGS. 40-43 show an exemplary mode of operation of sample managementassembly (4310). As can be seen in FIG. 40, sample management assembly(4310) initially begins with each tissue opening (4313) positioned intoalignment with a 12 o'clock position. Although not shown, it should beunderstood that in this position, each tissue opening (4313) ofrotational cam plates (4312) is aligned with cutter bore (4304) of outercover (4302). Accordingly, tissue manipulation feature (4319) of thecombination of all of the rotational cam plates (4312) is aligned withcutter bore (4304) such that sample management assembly (4310) is in aconfiguration to receive a tissue sample.

Tissue management assembly (4310) may be transitioned to the 12 o'clockposition shown in FIG. 40 by rotating drive shaft (4316) to therebyrotate rotational cam plates (4312). Once positioned, a tissue samplemay be acquired using biopsy device equipped with any one of probesdescribed above and/or in U.S. Pub. 2014/0039343. The tissue sample maythen be communicated through the cutter, through the distal wall (4303)of outer cover (4302) and into tissue manipulation feature (4319) asdefined by rotational cam plates (4312). Once a tissue sample isdisposed therein, an operator may inspect the tissue sample by visualinspection. It should be understood that outer cover (4302) istransparent as the outer cover is similarly described above.Additionally, in other aspects, sample management assembly (4310) isoptionally equipped with various other tissue analysis featuresdescribed herein.

Once an operator has competed analysis, it may be desirable to depositthe tissue sample into sample basket (4330) and thereby prepare samplemanagement assembly (4310) for receipt of another tissue sample. Totransport the tissue sample into sample basket (4330), rotational camplates (4312) are rotated via drive shaft (4316). In particular, as canbe seen in FIGS. 41-43, drive shaft (4316) is rotated in a counterclockwise direction via rotation member (4180) to drive each rotationalcam plate (4312) in a rotary motion relative to each stationary camplate (4320). As each rotational cam plate (4312) is rotated relative toeach stationary cam plate (4320), the effective size of tissuemanipulation feature (4319) progressively decreases due to theprogressively increasing radius of each stationary cam plate (4320).

Once each rotational cam plate (4312) is rotated into the position shownin FIG. 42, the tissue sample may fall into sample basket (4330) underthe force of gravity. However, depending on the particularcharacteristics of the tissue sample, in some instances the tissuesample may be susceptible to light adhesion such that the force ofgravity is insufficient to release the tissue sample into sample basket(4330). Additionally, in some uses tissue sample holder (4300) may beoriented such that the force of gravity is applied in a direction up thepage of FIG. 42. In such circumstances, the tissue sample gravity willnot force the tissue sample into sample basket (4330) regardless of theproperties of the tissue sample. In such instances, rotation ofrotational cam plates (4312) may continue relative to stationary camplates (4320) to the position shown in FIG. 43.

Once rotational cam plates (4312) have been rotated to the positionshown in FIG. 43, the effective size of tissue manipulation feature(4319) is reduced to nearly zero such that each tissue opening (4313) ofeach rotational cam plate (4312) is disposed substantially withinstationary cam plates (4320). Thus, as each rotational cam plate (4312)rotates toward the position shown in FIG. 43, each stationary cam plate(4320) will begin to engage the tissue sample and thereby mechanicallyforce the tissue sample away from rotational cam plates (4312). Once thetissue sample is separated from rotational cam plates (4312), the tissuesample will drop into sample basket (4330) or remain lightly adhered tostationary cam plates (4312). Rotational cam plates (4312) can thencontinue to rotate back to the position shown in FIG. 40 with samplemanipulation feature (4319) cleared of the tissue sample and preparedfor receipt of another tissue sample.

Once sample manipulation feature (4319) has been cleared by rotation ofrotational cam plates (4312) through the sequence described above,another tissue sample may be collected and deposited in sample basket(4330) by following the same sequence described above. The sequence maythen be repeated until sample basket (4330) is full, or until anoperator has completed the biopsy procedure.

FIGS. 45-46 show an alternative sample management assembly (5310) thatmay be readily incorporated into any one of the probes described aboveand/or in U.S. Pub. No. 2014/0039343. Sample management assembly (5310)is incorporated into a tissue sample holder (5300) that is substantiallysimilar to tissue sample holders (1300, 2300) described above. It shouldbe understood that unless otherwise specifically noted herein, tissuesample holder (5300) is identical to tissue sample holders (1300, 2300)described above. For instance, tissue sample holder (5300) of thepresent aspect is configured to store tissue samples in a single bulktissue sample chamber (5346). As is best seen in FIG. 45, tissue sampleholder (5300) comprises a sample basket (5330), a sample managementassembly (5310), and an outer cover (5302). Sample basket (5330) issubstantially similar to sample baskets (1330, 2330) described above.For instance, basket (5330) is generally configured to hold a pluralityof tissue samples in a single tissue sample chamber (5346). As can beseen, basket (5330) comprises a grip (5332) and a proximal wall (5334).Grip (5332) extends proximally from proximal wall (5334) and isconfigured to be grasped by an operator to manipulate basket (5330). Aswill be described in greater detail below, grip (5332) of the presentaspect is additionally configured to provide a fluid channelingfunction. Proximal wall (5334) defines a channel (not shown) along theouter edge of the distal side of proximal wall (5334). The channel isconfigured to receive at least a portion of outer cover (5302) tofluidly seal the proximal end of tissue sample holder (5300) when basket(5330) is disposed in outer cover (5302). Although not shown, it shouldbe understood that the channel can be equipped with gaskets or othersealing elements to further promote sealing between basket (5330) andouter cover (5302).

A pair of sidewalls (5344) and a lower floor (5340) extend distally fromproximal wall (5334). In the present aspect, sidewalls (5344) and lowerfloor (5340) are defined by a single semi-circular shaped member.However, it should be understood that in other aspects sidewalls (5334)and lower floor (5340) are more discretely defined by a square orrectangular cross-section. Although not shown, it should be understoodthat in some aspects basket (5330) includes an intermediate floor (notshown) disposed above lower floor (5340) as similarly described abovewith respect to baskets (1330, 2330).

A distal wall (5336) is disposed at the distal end of basket (5330).Distal wall (5336) of the present aspect defines a semi-circular shapethat is configured to receive at least a portion of sample managementassembly (5310), as will be described in greater detail below. Distalwall (5336), proximal wall (5334), sidewalls (5344), and theintermediate floor together define a tissue sample chamber (5346).Tissue sample chamber (5346) is generally configured to receive aplurality of tissue samples therein. In the present aspect, tissuesample chamber (5346) is configured to receive anywhere between about 20to about 50 tissue samples. Of course, in other aspects tissue samplechamber (5346) may be configured to receive any other suitable number oftissue samples.

Outer cover (5302) of the present aspect is substantially similar toouter covers (1302, 2302) described above. For instance, outer cover(5302) of the present aspect comprises a generally hollow cylindricalshape that is configured to receive basket (5330) and sample managementassembly (5310). Additionally, outer cover (5302) of the present aspectis substantially transparent to permit analysis of tissue samplesthrough outer cover (5302). However, unlike outer covers (1302, 2302)described above, outer cover (5302) of the present aspect is connecteddirectly to tube (5020) to supply vacuum directly to outer cover (5302).Although outer cover (5302) of the present aspect is shown as connectingdirectly to tube (5020), it should be understood that no such limitationis intended. For instance, in some aspect tube (5020) is connected toouter cover (5302) and the rest of tissue sample holder (5300) assimilarly described above with respect to tissue sample holders (1300,2300).

Sample management assembly (5310) is generally configured to selectivelydeposit tissue samples into sample basket (5330) while overcomingdifficulties associated with the tendency of tissue samples to lightlyadhere or stick to surfaces. As can best be seen in FIGS. 45-47, samplemanagement assembly (5310) generally comprises a sample receiving member(5312) and a release member (5320). Sample receiving member (5312) ofthe present aspect extends proximally from any one of probes describedabove and/or in U.S. Pub. No. 2014/0039343. To permit analysis of anytissue samples received in sample receiving member (5312), it should beunderstood that sample receiving member (5312) is generally transparent.Thus, an operator may visually analyze tissue samples as they arecollected in sample receiving member (5312).

Sample receiving member (5312) of the present aspect is in directcommunication with the cutter of any one of probes described aboveand/or in U.S. Pub. No. 2014/0039343. In particular, as can be seen inFIG. 47, the distal end of sample receiving member (5312) includes asample passage (5313) that is configured to communicate tissue samplesinto an interior chamber (5318) defined by tissue receiving member(5312). In order to receive tissue samples, sample receiving member(5312) generally comprises a hollow box or container with a generallytrapezoidal cross-sectional shape. In the present aspect, interiorchamber (5318) is generally sized to receive at least one tissue sample.In other aspects, interior chamber (5318) is sized to receive anysuitable number of tissue samples. Alternatively, in other aspectsinterior chamber (5318) is sized to closely approximate the size of asingle tissue sample such that interior chamber (5318) is sized toreceive only a single tissue sample.

To complete the vacuum circuit between the cutter and tube (5020),sample receiving member (5312) includes a fluid filter (5314) disposedon the distal end of sample receiving member (5312). Fluid filter (5314)comprises a plurality of openings (5316) extending through the proximalend of sample receiving member (5312). Openings (5216) are generallysized to permit the flow of fluid or tissue particles therethrough butblock tissue samples.

The underside of sample receiving member (5312) includes an open bottom(5319). As will be described in greater detail below, open bottom (5319)is generally closed by release member (5320). However, in operation ofsample management assembly (5310), release member (5320) can moverelative to sample receiving member (5312) to expose open bottom (5319).Thus, it should be understood that open bottom (5319) is generallyselectively transitionable between an open and closed configuration topermit receiving and releasing of tissue samples.

Release member (5320) comprises a blocking portion (5322) and anactuation portion (5326). Blocking portion (5322) comprises a solidblock with a generally triangular lateral cross-sectional shape.Blocking portion (5322) defines an upper surface (5324) that isconfigured to correspond to the size and shape of open bottom (5319) insample receiving member (5312). Although not shown, it should beunderstood that in some aspects upper surface (5324) includes certainsealing features such as gaskets, wiper seals, and the like that areconfigured to seal open bottom (5319) relative to the interior of outercover (5302). Various sealing features that may be incorporated intoupper surface (5324) will be apparent to those of ordinary skill in theart in view of the teachings herein.

Actuation portion (5326) of release member (5320) extends distally fromblocking portion (5322). Actuation portion (5326) is generallyconfigured to transmit torque to blocking portion (5322) to therebyrotate blocking portion (5322). In particular, the distal end ofactuation portion (5326) is equipped with a gear (5328). Gear (5328) isconfigured to be driven by various components of biopsy device such thatbiopsy device can drive gear (5328) to rotate blocking portion (5322)via actuation portion (5326). As will be described in greater detailbelow, this permits biopsy device to selectively block and unblock openbottom (5319) of sample receiving member (5312) using release member(5320).

An exemplary mode of operation of sample management assembly (5310) canbe seen by comparing FIGS. 46-48. As can be seen in FIG. 46, tissuemanagement assembly (5310) initially begins in a tissue receiving state.In the tissue receiving state, release member (5320) is positioned suchthat blocking portion (5322) is positioned directly under open bottom(5319) of sample receiving member (5312) to substantially seal openbottom (5319).

When sample management assembly (5310) is in the tissue receiving state,one or more tissue samples may be communicated from the cutter and intointerior chamber (5318) of sample receiving member (5312). Inparticular, vacuum may be applied to tube (5020) and travel into outercover (5302). Vacuum may then pass through openings (5316) of fluidfilter (5314) and into interior chamber (5318). Because interior chamber(5318) is in direct communication with the cutter through sample passage(5313), vacuum will pass through interior chamber (5318) and into thecutter to transport one or more tissue samples into interior chamber(5318).

Once one or more tissue samples are received within interior chamber(5318), an operator may visually analyze the one or more tissue samples.It should be understood that in some aspects sample receiving member(5312) is also equipped with various other sample analysis featuresdescribed herein (e.g., bioimpedance). Thus, during this stage, the oneor more tissue samples can also be analyzed using any other sampleanalysis feature.

At the conclusion of sample analysis, an operator may desire to emptythe contents of interior chamber (5318) into sample basket (5330). Toempty interior chamber (5318) an operator can selectively transitionsample management assembly (5310) into a sample release configurationshown in FIG. 48. In the sample release configuration, release member(5320) is rotated relative to sample receiving member (5312) via gear(5328) to expose open bottom (5319) of sample receiving member (5312).This will permit the one or more tissue samples to drop into samplebasket (5330). Additionally, if any tissue samples stick or otherwiseadhere to upper surface (5324) of blocking portion (5322) such sampleswill be removed as blocking portion (5322) is rotated relative to samplereceiving member (5312). In particular, because upper surface (5324) isclosely associated with open bottom (5319), sample receiving member(5312) will push any tissue sample off of upper surface (5324) as uppersurface (5324) is moved relative to open bottom (5319).

Once the one or more tissue samples have been deposited in sample basket(5330), sample management assembly (5310) may be returned to the tissuereceiving state shown in FIG. 46. Once back in the sample receivingstate, additional tissue samples may be acquired by repeating theprocess described above. This process may be repeated by an operatorseveral times until sample basket (5330) is full or until the conclusionof the biopsy procedure.

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

EXAMPLE 1

A biopsy device, comprising: (a) a body; (b) a needle extending distallyfrom the body; (c) a cutter movable relative to the needle and incommunication with the needle for transporting tissue samples; and (d)an analysis area disposed proximally of the cutter and in communicationwith the needle to receive a tissue sample cut by the cutter foranalysis by a user; (e) a valve disposed proximally of the anlysis areaand configured to alternate between an open configuration and a closedconfiguration; and (f) a tissue sample holder disposed proximally of thevalve and fixedly attached to the body, wherein the valve is configuredto permit analysis of the sample disposed in the analysis area when thevalve is in the closed configuration and to permit the tissue sample tobe passed into the tissue sample holder when the valve is in the openconfiguration.

EXAMPLE 2

The biopsy device of Example 1, wherein at least a portion of the tissuesample holder is releasably attached to the body.

EXAMPLE 3

The biopsy device of Example 2, wherein the valve incudes a movablefilter, wherein the analysis area defines a single tissue samplechamber, wherein the single tissue sample chamber is in selectivecommunication with the tissue sample holder via selective movement ofthe filter.

EXAMPLE 4

The biopsy device of any one or more of Example 1, wherein the valveincludes a first disk, wherein the first disk includes a plurality ofouter filter portions and a plurality of openings, wherein each outerfilter portion is positioned adjacent to a corresponding opening suchthat the plurality of outer filter portions and the plurality ofopenings form an alternating arrangement.

EXAMPLE 5

The biopsy device of Example 4, wherein the first disk is configured torotate relative to the cutter to successively and alternatingly align anouter filter portion or opening with the cutter.

EXAMPLE 6

The biopsy device of Example 5, wherein the valve is configured toprovide the closed configuration when an outer filter portion of thefirst disk is aligned with the cutter, wherein the valve is configuredto provide the open configuration when an opening of the first disk isaligned with the cutter.

EXAMPLE 7

The biopsy device of Example 6, wherein the valve further includes asecond disk, wherein the second disk includes a plurality of vacuumchambers and a plurality of openings.

EXAMPLE 8

The biopsy device of Example 7, wherein the first disk is fixedlysecured to the second disk.

EXAMPLE 9

The biopsy device of Example 7, wherein each vacuum chamber of thesecond disk is configured to correspond to a respective outer filterportion of the first disk, wherein each opening of the second disk isconfigured to correspond to a respective opening of the second disk.

EXAMPLE 10

The biopsy device of Example 9, wherein the first disk further includesa filter ring, wherein the filter ring is defined by a plurality ofvacuum openings extending through the first disk, wherein each vacuumchamber of the second disk is configured to redirect vacuum flowingthrough the filter ring of the first disk to a respective filter portionof the first disk.

EXAMPLE 11

The biopsy device of any one or more of Examples 1 through 10, whereinthe analysis area includes a sample window, wherein the sample window isconfigured to permit visual analysis of tissue samples.

EXAMPLE 12

The biopsy device of any one or more of examples Example 1 through 11,wherein the analysis area includes one or more electrodes, wherein theone or more electrodes are configured to detect impedance of tissuesamples.

EXAMPLE 13

The biopsy device of Example 1, wherein the tissue sample holderincludes an outer cup and a bulk tissue sample basket removably disposedwithin the outer cup.

EXAMPLE 14

The biopsy device of any one or more of Examples 13, wherein the outercup is releasable attached to the body.

EXAMPLE 15

The biopsy device of any one or more of Examples 13, wherein the bulktissue sample basket defines a sample collection area, wherein thesample collection area is sized to receive from about 10 to about 50tissue samples.

EXAMPLE 16

A biopsy system, comprising: (a) a biopsy device, wherein the biopsydevice includes: (i) a body, (ii) a needle, (iii) a cutter, wherein theneedle extends from the body to collect tissue samples using the cutter,(iv) a sample analyzer, wherein the sample analyzer includes a gate,wherein the gate is configured to selectively arrest movement of atissue sample within the sample analyzer for analysis, (v) a tissuesample holder, wherein the tissue sample holder is in communication withthe sample analyzer, wherein the tissue sample holder is configured toreceive tissue samples after analysis by the sample analyzer; and (b) acontrol module, wherein the control module is in communication with thebiopsy device.

EXAMPLE 17

The biopsy system of Example 16, wherein the gate is configured totransition between an open and closed position to selectively arrest atissue sample before transport to the tissue sample holder.

EXAMPLE 18

The tissue sample holder of Example 16, wherein the analyzer furtherincludes a sample lumen and a first detector in communication with thecontrol module, wherein the first detector protrudes into the firstlumen, wherein the first lumen is in communication with the cutter toreceive a tissue sample therein.

EXAMPLE 19

The tissue sample holder of Example 16, wherein the sample analyzerincludes a tissue window, wherein the tissue window is disposed withinthe body of the biopsy device and is sealed relative to an exterior ofthe biopsy device.

EXAMPLE 20

A biopsy device, comprising: (a) a body; (b) a needle; (c) a cutter; and(d) a tissue handling assembly in communication with the cutter, whereinthe tissue handling assembly includes: (i) a sample viewer integratedinto the body, wherein the sample viewer is configured to permitanalysis of tissue samples as they are received by the tissue handlingassembly from the cutter, (ii) a bulk collection tray, wherein the bulkcollection tray is configured to receive a plurality of tissue samples,and (iii) a tissue gate, wherein the tissue gate is positioned betweenthe tissue analysis feature and the bulk collection tray, wherein thetissue gate is configured to selectively control transport of tissuesamples between the sample viewer and the bulk collection tray.

EXAMPLE 21

A tissue sample holder, comprising: (a) an outer cover; (b) a tissuereceiving member; and (c) a sample management assembly, wherein thesample management assembly comprises first plurality of plates and asecond plurality plates, wherein each plate of the first plurality ofplates is alternatingly disposed between each plate of the secondplurality of plates, wherein the first plurality of plates areconfigured to move rotationally relative to the second plurality ofplates to manipulate a tissue sample into the tissue receiving member.

EXAMPLE 22

The tissue sample holder of claim 21, wherein each plate of the firstplurality of plates comprises a tissue groove, wherein the tissue grooveof each plate is configured to align with the tissue grooves of theother first plurality of plates to define a tissue manipulation chamber.

EXAMPLE 23

The tissue sample holder of Example 22, wherein the tissue manipulationchamber is configured to receive a single tissue sample.

EXAMPLE 24

The tissue sample holder of any one or more of Examples 21 or 22,wherein the tissue manipulation chamber is configured to move relativeto the second plurality of plates in response to movement of the firstplurality of plates.

EXAMPLE 25

The tissue sample holder of Example 24, wherein each tissue groove ofeach plate of the first plurality of plates is configured toprogressively retract relative to the second plurality of plates as thefirst plurality of plates move relative to the second plurality ofplates.

EXAMPLE 26

The tissue sample holder of Example 25, wherein retraction of eachtissue groove of each plate of the first plurality of plates isconfigured to progressively decrease the effective size of the tissuemanipulation chamber.

EXAMPLE 27

The tissue sample holder of any one of Examples 21 through 26, the outercup comprises a first member and a second member, wherein each of thefirst member and second member is configured to engage each plate of thesecond plurality of plates.

EXAMPLE 28

The tissue sample holder of Example 27, wherein the first member andsecond member are configured to maintain each plate of the secondplurality of plates in a single position relative to the first pluralityof plates.

EXAMPLE 29

The tissue sample holder of any one or more of Examples 21 through 28,wherein the sample management assembly further comprises a drive shaft,wherein the drive shaft connects the first plurality of plates and thesecond plurality of plates.

EXAMPLE 30

The tissue sample holder of Example 29, wherein the drive shaft is keyedto the first plurality of plates such that the drive shaft is configuredto transfer rotational motion to the first plurality of plates.

EXAMPLE 31

The tissue sample holder of Example 30, wherein the drive shaft isconfigured to rotate relative to the second plurality of plates.

EXAMPLE 32

The tissue sample holder of any one or more of Examples 21 through 30,further comprising a sample analysis assembly, wherein the sampleanalysis assembly is associated with the sample management assembly.

EXAMPLE 33

The tissue sample holder of Example 32, wherein the sample analysisassembly is configured to permit visual analysis of tissue samples.

EXAMPLE 34

The tissue sample holder of any one or more of Examples 32 or 33,wherein the sample analysis assembly is configured to permit bioimpedance analysis of tissue samples.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

By way of aspect only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide or steam.

Embodiments of the devices disclosed herein can be reconditioned forreuse after at least one use. Reconditioning may include any combinationof the steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, embodiments of the devices disclosed herein may bedisassembled, and any number of the particular pieces or parts of thedevices may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevices may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, the aspects,embodiments, geometries, materials, dimensions, ratios, steps, and thelike discussed above are illustrative and are not required. Accordingly,the scope of the present invention should be considered in terms of thefollowing claims and is understood not to be limited to the details ofstructure and operation shown and described in the specification anddrawings.

We claim:
 1. A biopsy device, comprising: (a) a body; (b) a needle extending distally from the body; (c) a cutter movable relative to the needle and in communication with the needle for transporting tissue samples; (d) a visual inspection area disposed in the body proximally of the cutter and in communication with the needle to receive a tissue sample cut by the cutter for visual inspection by a user; (e) a valve configured to alternate between an open configuration and a closed configuration; and (f) a tissue sample holder disposed proximally of the valve, the valve being disposed proximally of the visual inspection area and distally of the tissue sample holder such that the tissue sample holder, valve, and visual inspection area are arranged collinearly, the valve being configured to permit visual inspection of the sample disposed in the visual inspection area when the valve is in the closed configuration and to permit the tissue sample to be passed into the tissue sample holder when the valve is in the open configuration.
 2. The biopsy device of claim 1, at least a portion of the tissue sample holder releasably attached to the body.
 3. The biopsy device of claim 1, the valve including a movable filter, the visual inspection area defining a single tissue sample chamber, the single tissue sample chamber being in selective communication with the tissue sample holder via selective movement of the filter.
 4. The biopsy device of claim 1, the valve including a first disk, the first disk including a plurality of outer filter portions and a plurality of openings, each outer filter portion being positioned adjacent to a corresponding opening such that the plurality of outer filter portions and the plurality of openings form an alternating arrangement.
 5. The biopsy device of claim 4, the first disk being configured to rotate relative to the cutter to successively and alternatingly align an outer filter portion or opening with the cutter.
 6. The biopsy device of claim 5, the valve being configured to provide the closed configuration when an outer filter portion of the first disk is aligned with the cutter, the valve being configured to provide the open configuration when an opening of the first disk is aligned with the cutter.
 7. The biopsy device of claim 6, the valve further including a second disk, the second disk including a plurality of vacuum chambers and a plurality of openings.
 8. The biopsy device of claim 7, the first disk being fixedly secured to the second disk.
 9. The biopsy device of claim 7, each vacuum chamber of the second disk being, configured to correspond to a respective outer filter portion of the first disk, each opening of the second disk being configured to correspond to a respective opening of the disk.
 10. The biopsy device of claim 9, the first disk further including a filter ring, the filter ring being defined by a plurality of vacuum openings extending through the first disk, each vacuum chamber of the second disk being configured to redirect vacuum flowing through the filter ring of the first disk to a respective filter portion of the first disk.
 11. The biopsy device of claim 1, the visual inspection area including a sample window, the sample window being configured to permit visual analysis of tissue samples.
 12. The biopsy device of claim 1, the visual inspection area including one or more electrodes, the one or more electrodes being configured to detect impedance of tissue samples.
 13. The biopsy device of claim 1, the tissue sample holder including an outer cup and a bulk tissue sample basket removably disposed within the outer cup.
 14. The biopsy device of claim 13, the outer cup being releasably attached to the body.
 15. The biopsy device of claim 13, the hulk tissue sample basket defining a sample collection area, the sample collection area being sized to receive from about 10 to about 50 tissue samples.
 16. A biopsy device, comprising: (a) a body; (b) a needle extending distally from the body; (c) a cutter defining a transport axis and movable relative to the needle and in communication with the needle for transporting tissue samples; (d) an inspection window disposed in the body proximally of the cutter, the inspection window being configured to receive a tissue sample cut by the cutter for visual inspection by a user; (e) a sample management assembly disposed proximally of the inspection window and configured to transition between a tissue transport configuration and a tissue stopping configuration; and (f) a tissue sample holder disposed proximally of the sample management assembly, the sample management assembly being configured to permit visual inspection of the tissue sample disposed in the inspection window when the sample management assembly is in the sample stopping configuration and to permit the tissue sample to be passed along the transport axis defined by the cutter and into the tissue sample holder when the sample management assembly is in the transport configuration.
 17. The biopsy device of claim 16, the sample management assembly including a filter portion having a plurality of openings configured to promote a flow of vacuum through the sample management assembly when the sample management assembly is in the tissue stopping configuration.
 18. The biopsy device of claim 17, the sample management assembly including a rotatable disk, the rotatable disk defining the filter portion.
 19. The biopsy device of claim 16, at least a portion of the sample management assembly being configured to move relative to the body to transition the sample management assembly between the tissue transport configuration and the tissue stopping configuration.
 20. A biopsy device, comprising: (a) a body; (b) a needle extending distally from the body; (c) a cutter defining a sampling axis and movable relative to the needle and in communication with the needle for transporting tissue samples; (d) a visual inspection area disposed in the body, the visual inspection area including an inspection window, the visual inspection area being configured to receive a tissue sample cut by the cutter for visual inspection through the inspection window; (e) a sample management assembly configured to transition between a tissue transport configuration and a tissue stopping configuration; and (f) a tissue sample holder, the sample management assembly being disposed along the sampling axis between the inspection window and the tissue sample holder, the sample management assembly being configured to permit visual inspection of the sample disposed in the visual inspection area when the sample management assembly is in the tissue stopping configuration and to permit the tissue sample to be passed into the tissue sample holder when the sample management assembly is in the transport configuration. 